FDA Registration
Active
🇺🇸 United States
COOPERSURGICAL, INC.
Reg #: 1216677
·
FEI: 1216677
·
Expires 2026
Products
97
Proprietary Names
571
Establishment Types
5
Classifications
97
Registration Details
- Registration Name
- COOPERSURGICAL, INC.
- Registration Number
- 1216677
- FEI Number
- 1216677
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 95 CORPORATE DRIVE
- City
- Trumbull
- State
- CT
- ZIP
- 06611
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020951
Owner / Operator
- Firm Name
- COOPERSURGICAL, INC.
- Operator Number
- 9002384
- Address
- 95 CORPORATE DRIVE, --
- City
- Trumbull
- State
- CT
- Postal Code
- 06611
- Country
- US
- Correspondent
- Brian Szeremeta
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Manipulator/Injector, Uterine | LKF | Class 2 | Obstetrics/Gynecology | No | 2008-03-12 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2010-07-28 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2008-03-17 |
| Cannula, Intrauterine Insemination | MFD | Class 2 | Obstetrics/Gynecology | No | 2008-03-12 |
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2026-06-16 |
| Needle, Assisted Reproduction | MQE | Class 2 | Obstetrics/Gynecology | No | 2018-06-21 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2008-03-17 |
| Electrocautery, Gynecologic (And Accessories) | HGI | Class 2 | Obstetrics/Gynecology | No | 2008-04-17 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2008-03-18 |
| Catheter, Assisted Reproduction | MQF | Class 2 | Obstetrics/Gynecology | No | 2018-05-01 |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | Class 1 | Obstetrics/Gynecology | No | 2002-09-11 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2010-02-01 |
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2008-03-12 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2010-07-28 |
| Unit, Cryotherapy, Ophthalmic | HQA | Class 2 | Ophthalmic | No | 2010-03-04 |
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2015-06-03 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2012-11-06 |
| Monitor, Heart Sound, Fetal, Ultrasonic | HEK | Class 2 | Obstetrics/Gynecology | No | 2012-11-06 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2021-05-19 |
| Extractor, Vacuum, Fetal | HDB | Class 2 | Obstetrics/Gynecology | No | 2008-03-17 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2008-03-18 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2008-03-18 |
| Culdoscope (And Accessories) | HEW | Class 2 | Obstetrics/Gynecology | No | 2015-08-26 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2008-03-18 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2001-09-18 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2008-03-18 |
| Brush, Endometrial | HFE | Class 2 | Obstetrics/Gynecology | No | 2006-07-28 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 1999-03-15 |
| Accessory, Assisted Reproduction | MQG | Class 2 | Obstetrics/Gynecology | No | 2014-12-04 |
| Intrauterine Tamponade Balloon | OQY | Class 2 | Obstetrics/Gynecology | No | 2025-12-05 |
| Stapler, Skin | QQS | Class 1 | General Hospital | No | 2023-11-06 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2021-05-19 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2009-05-01 |
| Cap, Cervical | HDR | Class 2 | Obstetrics/Gynecology | No | 2008-03-12 |
| Pessary, Vaginal | HHW | Class 2 | Obstetrics/Gynecology | No | 2008-03-14 |
| Punch, Biopsy, Surgical | EME | Class 1 | Dental | No | 1994-01-31 |
| Curette, Suction, Endometrial (And Accessories) | HHK | Class 2 | Obstetrics/Gynecology | No | 2008-08-18 |
| Trocar | DRC | Class 2 | Cardiovascular | No | 2011-09-02 |
| Accessory, Assisted Reproduction, Exempt | PUB | Class 2 | Obstetrics/Gynecology | No | 2020-02-25 |
| Semen Analysis Device | POV | Class 2 | Hematology | No | 2020-01-10 |
| Aspirator, Endocervical | HFC | Class 2 | Obstetrics/Gynecology | No | 2008-03-13 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2009-01-12 |
| Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor | PFJ | Class 2 | Obstetrics/Gynecology | No | 2025-11-20 |
| Colposcope (And Colpomicroscope) | HEX | Class 2 | Obstetrics/Gynecology | No | 2008-03-18 |
| Aspirator, Endometrial | HFF | Class 2 | Obstetrics/Gynecology | No | 2008-03-18 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2004-03-01 |
| Instrument, Manual, Specialized Obstetric-Gynecologic | KNA | Class 2 | Obstetrics/Gynecology | No | 2009-02-18 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2008-03-13 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2026-06-18 |
| Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) | HES | Class 2 | Obstetrics/Gynecology | No | 2008-03-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2008-03-18 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2007-12-06 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2008-03-17 |
| Diaphragm, Contraceptive (And Accessories) | HDW | Class 2 | Obstetrics/Gynecology | No | 2008-03-14 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2008-03-13 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 1999-03-15 |
| Monitor, Blood-Flow, Ultrasonic | HEP | Class 2 | Obstetrics/Gynecology | No | 2012-11-06 |
| Monitor, Ultrasonic, Fetal | KNG | Class 2 | Obstetrics/Gynecology | No | 2012-11-06 |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | Class 1 | Physical Medicine | No | 2017-02-08 |
| Monitor, Ultrasonic, Nonfetal | JAF | Class 2 | Radiology | No | 2012-11-06 |
| Microtools, Assisted Reproduction (Pipettes) | MQH | Class 2 | Obstetrics/Gynecology | No | 2016-01-14 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2020-02-11 |
| Amniotome | HGE | Class 1 | Obstetrics/Gynecology | No | 2002-02-23 |
| Set, Anesthesia, Paracervical | HEE | Class 2 | Obstetrics/Gynecology | No | 2013-01-09 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2008-03-17 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2001-12-26 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 1977-12-09 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2003-05-09 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2016-05-10 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2010-03-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2010-02-01 |
| Sampler, Endocervical | PCF | Class 2 | Obstetrics/Gynecology | No | 2016-06-20 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2003-05-09 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 1999-03-15 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2014-10-20 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2008-03-17 |
| Support, Breathing Tube | JAY | Class 1 | Anesthesiology | No | 2003-05-09 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2008-03-17 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2012-11-06 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2011-09-02 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2001-09-18 |
| Dilator, Rectal | FFP | Class 1 | Gastroenterology, Urology | No | 2005-02-17 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2019-11-18 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2019-11-18 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1977-12-09 |
| Fetal Head Elevator | PWB | Class 2 | Obstetrics/Gynecology | No | 2024-12-11 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2025-09-19 |
| Transducer, Ultrasonic | JOP | Class 2 | Cardiovascular | No | 2025-09-19 |
| Monitor, Fetal Doppler Ultrasound | MAA | Class 2 | Obstetrics/Gynecology | No | 2012-11-06 |
| Pneumoperitoneum Needle | FHO | Class 2 | Gastroenterology, Urology | No | 2011-09-02 |
| Endoscopic Irrigation/Suction System | OCX | Class 2 | Gastroenterology, Urology | No | 2013-07-02 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 2010-09-10 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 1977-12-09 |
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2011-01-04 |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | Class 2 | Obstetrics/Gynecology | No | 2019-09-17 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2025-08-29 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2003-05-09 |
Proprietary Names
H/S [Elliptosphere] Catheter
Holder, Needle (Multi. REDA)
Hysterosalpingogram Tray
TheCurve
10620010D
Biopsy Medium
10620010A
10620010F
10620010
10620010M
ZUMI [Uter.Manip./Inject.w/spring]
UNI-SEM (TM)
Wallace Oocyte Needles
BlastGen
12050003
12050003D
12050003A
12050003M
12050003F
1205
Esophageal Balloon Cath.[Ackrad]
LEEP Electrodes
WA 1000 Console
Protein Supplement
LGPS-020M, LGPS-050M, LGPS-605M
LGPS-020, LGPS-050, LGPS-100, LGPS-125, LGPS-250, LGPS-605
Embryo Replacement Catheter (Wallace)
LifeGlobal® Global® Total® LP for Fertilization
LifeGlobal® Global® Total® w/HSA
LifeGlobal® Global® Total® for Fertilization w/HSA
LifeGlobal® Global® Total® LP
LifeGlobal® Global® Total® LP w/Hepes
LifeGlobal® Global® Total® w/HEPES w/HSA
KC-SIZER
Apple's Vaginal Probe for Laparoscopy [900-590]
CSI's Guardian Vaginal Retractor
Scissors
Cytobrush Plus / Plus GT
SAGE Vitrification Warming Kit
SAGE Vitrification Kit
SAGE Vitrification Warming Kit
ViaBL Super-Fast Blastocyst Warming Kit ART-8035
ART-8035, ART-8035A, ART-8035D
ViaBL(TM) SUPER-FAST VITRIFICATION KIT ART-8023/ART-8023D/ART-8023M
Aspirating (multi)
Euromed Curette, Biopsy &
CE-2000 Ophthalmic Cryosurgery Sys.
Pasteur Pipets
Summit
PVP 10%
Polyvinylpyrrolidon (PVP) 10%
PVP 7%
17G Wallace Dual Lumen
Integration Unit [use w/SmokeEvac.]
ORIGIO Sequential Blast
83050010, 83050060, 83060010, 83060060
83050010A, 83050060A, 83060010A, 83060060A
83050010D, 83050060D, 83060010D, 83060060D
83050010M, 83050060M, 83060010M, 83060060M
83050010F, 83050060F, 83060010F, 83060060F
Wallace Embryo Transfer Catheter
INSORB Subcuticular Skin Stapler
MityVac Super M-Style Cup, dispos.
Carter-Thomason[CT] CloseSureSys.
Frigi. Cryo Surg Model 5900
Vitrification Warming Kit
Vitrification Kit &
H/S Elliptosphere Procedure Tray
HS Catheter Trays
Biovac Smoke Evacuator
Quantum 2000 ESU
Advincular Delineator
Ally UPS
Dopplers,Multi., Fetal & Blood Flow
WA-2000 Temperature Indicator
Uterobrush
LGFR-100M, LGFR-500M
Global w/HEPES LGGH-050, LGGH-050, LGGH-250, LGGH-500
Washing mHTF w/HEPES & Phenol Red
Media Culture System
global Collect
Global w/Hepes
PGD Media
HTF w/Hepes
Global w/HEPES LGGH-050M, LGGH-050M, LGGH-250M, LGGH-500M
LGFR-100, LGFR-500
Global Collect GCOL-100, GCOL-500
Global Collect GCOL-100M, GCOL-500M
Instruments, Disposable (multi.)
RUMI System [Mfg]
RUMI II & RUMI Arch II Handles [SD]
RUMI II & RUMI Arch II Handles [Mfg]
Origio Gas Line Filter
J-SOS-100500 - Bakri Tamponade Balloon Catheter
INSORB Subcuticular Stapler- REF 2030
INSORB SEQUENTIAL FORCEPS
H/Stylet, 61-0020
Sperm Select System
Milex Silicone Pessaries
Apple - Fischer Cone Biopsy Excisor
Euro-Med Skin Punch
[Skin Punch]
DISPOSA-DERM
10890001A, 10905000A
PVP Clinical Grade
PVP Medium
PVP Clinical Grade 10905000
10890001D, 10905000D
PVP Medium 1089
10890001M, 10905000M
PVP Medium 10890001
PVP Clinical Grade 1090
10890001F, 10905000F
Custom IVF Workstation
Pipelle
Mystic Disposable Pump
Apple-Hunt Secondary Cannula
Acidified Tyrodes Solution
K-SYSTEMS WORK STATIONS, TYPE, L-13W, L-13E, L-13ES, L-13ET, L-13EM
K-SYSTEMS WORK STATIONS, TYPE, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E, L
SignipHy Trakpod
ABBI
HBA
SpermSlow
10944000A
SpermSlow 1094
SpermSlow 10944000M
10944000D
SpermSlow 10944000
10944000F
INFLAT-O-BALL
Aspirette Endocervical Needle
J-Needle
Delineator Adapter Drape
LEEP Electrosurgery System &
J-CRBS-184000 - Cervical Ripening Balloon with Stylet
J-CRB-184000 - Cervical Ripening Balloon
Sperm Preparation Medium
10690060A, 10691010A, 10695060A, 10700060A, 10701010A, 10702010A, 10705060A
10690060D, 10691010D, 10695060D, 10700060D, 10701010D, 10702010D, 10705060D
10690060F, 10691010F, 10695060F, 10700060F, 10701010F, 10702010F, 10705060F
10690060M, 10691010M, 10695060M, 10700060M, 10701010M, 10702010M, 10705060M
QA Blastocyst Freeze Kit
QA Embryo Freeze Kit
QA Sperm Freeze Kit
QA Thaw Kit
MityVac w/Universal Vacuum Release
[UVR]
Wallach 'Star' Colposcope
Endocell [Endometrial Sampler]
MULTIPLE BIOPSY DEVICES
PERCUTANEOUS
Wallace Pessaries
Miya Hook
82331 - Sani-Spec® Disposable Specula - Large
82420 - Sani-Scope® Disposable Anoscope
8311 - Galenica Vaginal Specula - Large
82341 - Sani-Spec® Disposable Speculum - Medium
8616 - Galenica Medium Vaginal Speculum
8617 - Galenica Vaginal Specula - Large
82330 - Sani-Spec® Disposable Specula - Medium
8309 - Galenica Vaginal Specula - Small
82329 - Sani-Spec® Disposable Specula - Small
8310 - Galenica Vaginal Specula - Medium
82340 - Sani-Spec® Disposable Speculum - Small
8615 - Galenica Vaginal Specula - Small
Liquid Paraffin
Liquid Paraffin 1010
Liquid Paraffin 10105060
10100060A, 10105060A, 10100500A
Liquid Paraffin 10100060
10100060M, 10105060M, 10100500M
Liquid Paraffin 10100500
10100060D, 10105060D, 10100500D
10100060F, 10105060F, 10100500F
Human Serum Albumin
QA Medium w/HEPES
QA Fertilization Medium
QA Protein + Blastocyst Medium
QA Protein + Fert. Medium
QA Protein + Cleavage Medium
QA Blastocyst Medium
QA Cleavage Medium
Acidified Medium w/HEPES
HUI Mini-Flex[HarrisUterineInject.]
C110220 - ONETRAC LXS Yankauer
C110310 - ONETRAC LXS Frazier
C110200 - ONETRAC LXS Yankauer
C110210 - ONETRAC LXS Yankauer
C110320 - ONETRAC LXS Frazier
Wallace Oocyte Retrieval Needles
Kronner Manipujector
83100060M, 83100125M, 83110060M, 83110125M
ORIGIO Handling Medium
ORIGIO Handling Medium 83110125D
ORIGIO Handling Medium 8310
83100060F, 83100125F, 83110060F, 83110125F
ORIGIO Handling Medium 83110060D
83100060A, 83100125A, 83110060A, 83110125A
ORIGIO Handling Medium 83100060D
83100060, 83100125, 83110060, 83110125
ORIGIO Handling Medium 83100125D
ORIGIO Handling Medium 8311
Wallach Loop Electrodes
Inserter, Inguinal Reservoir
INCA [Infant Nasal Cannulae Assy]
Milex Wide-Seal Diaphragm
TRAKE-fit Tracheostomy Tube Holder
Euro-Med Hooks & Tenaculum
Forceps, Biopsy (multi.)
Phosphate Buffered Saline (PBS)
Embryo Corral Dish
Embryo GPS Dish
4-Welll GPS Dish
Universal GPS Dish
38Special GPS Dish
Mini GPS Dish
MGPS-010M ?Drop GPS® Dish
MGPS-010, UGPS-010, EGPS-010, EMBC-010, 4GPS-010, MI38-010, SP38-010
µDrop GPS Dish
MGPS-010M, UGPS-010M, EGPS-010M, EMBC-010M, 4GPS-010M, MI38-010M, SP38-010M
Advincula Delineator Flexible Soft Cup
Infant Heel Warmer / WarmGel Infant Heel Warmer
10300060A, 10301010A, 10305060A, 10310060A, 10311010A, 10315060A
Universal IVF Medium
10300060, 10301010, 10305060, 10310060, 10311010, 10315060
10300060F, 10301010F, 10305060F, 10310060F, 10311010F, 10315060F
10300060D, 10301010D, 10305060D, 10310060D, 10311010D, 10315060D
10300060M, 10301010M, 10305060M, 10310060M, 10311010M, 10315060M
PIPETTES
ER Peak & Embryo Biopsy Kits
AMNIOTOME
DISPOSABLE AMNIOTOME
Potocky Needle, Disposable Injection Needle
MityVac OB Vacuum Cup(s), Multi.
[Reusable]
Uterine Injector w/Spring [ZUI]
Pap-Perfect Plastic Spatula
TRANSWARMER
Apple Hunt Organizer
H/S Catheter [61-30## & 61-50##]
Ultrafreeze
TRAKEFIT TRACHEOSTOMY TUBE HOLDER
N-DOSURE
Vaginal-Silicone Dilators
Dil-Os
Dilator Cervical OS Finder
INFUSET AND IRRIJET STERILE SETS
Tis-U-Trap w/Metal Curette
Knot Pusher
6066 - Potocky Needle®
920009 - Wallach® Endocervical Block Kit
ULTRA PLUME AWAY - 6
Laparoscopic Smoke Evacuation Sys.
[SeeClear & Plume-Away]
PLUME AWAY - 4
J-SOSR-100500 - Cook Bakri Postpartum Balloon w rapid install components
LL 100 N2O Cryosurgical System &
Cryo Tips
REDA Hysterectomy Scissors (mult.)
REDA Z-clamp Forceps (mult.)
Pioneer Pumps
Pap-Perfect Multi-Test Tray
Kevor-Curette
EmbryoGen 12040003
EmbryoGen/BlastGen 12062003
12040003M, 12062003M
12040003A, 12062003A
12040003D, 12062003D
Endocervical Block Needle
Sequential Cleav 83030010, 83030060, 83040010, 83040060
83030010M, 83030060M, 83040010M, 83040060M
ORIGIO Sequential Cleav
ORIGIO Sequential Fert
Sequential Cleav w/o phenol red 8303
Sequential Cleav w/o phenol red 83030060
Sequential Cleav w/o phenol red 83030010
Sequential Cleav with phenol red 83040010
83010010F, 83010060F, 83020010F, 83020060F
83030010A, 83030060A, 83040010A, 83040060A
Sequential Fert with phenol red 8302
Sequential Fert 83010010, 83010060, 83020010, 83020060
83030010D, 83030060D, 83040010D, 83040060D
Sequential Fert with phenol red 83020060
Sequential Cleav with phenol red 83040060
83010010M, 83010060M, 83020010M, 83020060M
83010010D, 83010060D, 83020010D, 83020060D
83030010F, 83030060F, 83040010F, 83040060F
Sequential Fert with phenol red 83020010
83010010A, 83010060A, 83020010A, 83020060A
Sequential Fert w/o phenol red 83010060
Sequential Fert w/o phenol red 83010010
Sequential Cleav with phenol red 8304
Sequential Fert w/o phenol red 8301
Pioneer Pump
BlastThaw
BlastFreeze
10542010
10542010M
10542010F
10532010F
10542010D
10542010A
RAPP Laparoscopic Instruments
Nu-Tip Laparoscopic Instruments;
MityVac "M" Style Vacuum Cup
ZMH0850M - ZyMot Multi Sperm Separation Device
ZMH3000M - ZyMot Multi Sperm Separation Device
Marlow Balloon Cannulae, Family of
NEO-PREP SKIN BARRIER
Inseminator
Pipet Curet
10840125M, 10845060M
Flushing Medium w/o Heparin
Flushing medium
10840125, 10845060
10840125F, 10845060F
10840125D, 10845060D
10840125A, 10845060A
Scissors, Episiotomy & Parametrium [HBH & Zeppelin]
Global Total for Fertilization LGTF-020, LGTF-050, LGTF-100
Global Total LGGT-030M, LGGT-060M, LGGT-100M
Life Global Total for Fertilization
LifeGlobal Total w/HEPES
LifeGlobal Total
Global Total LGGT-030, LGGT-060, LGGT-100
Global Total for Fertilization LGTF-020M, LGTF-050M, LGTF-100M
Global Total w/HEPES LGTH-050M, LGTH-100M, LGTH-250M
Global Total w/HEPES LGTH-050, LGTH-100, LGTH-250
IRRIJET
CS-76 / CryoCare1 [Frigi.]
12284001D, 12295002D
Medicult Vitrification Cooling and Warming
12284001M, 12295002M
12284001 and 12295002 Medicult Vitrification Cooling and Warming
12284001F, 12295002F
12284001A, 12295002A
C Safe
HTF Media
FERTILIZATION MEDIA
Hyaluronidase 80 U/ml
PureCeption 24-Determination Bi-Layer Kit
PureCeption, Lower & Upper Phase
PureCeption 100% Isotonic Solution
METRA PS Procedure Kit
MediCult IVM System
82214010
82214010A
82214010D
82214010M
QA HTF Medium w/HEPES
Wallach 'Scope' Colposcope
6080 Smoke Evacuator Sys/Access.
NEO-FIT AND COMFIT END
Lumax TS Pro System
Wallace Dual Lumen 16G
Apple OB/Mobius Elastic Retractor
Stripper PGD
Stripper Tips
67020010D, 67020060D
SAGE 1-Step
67010010, 67010060
67010010D, 67010060D
67020010F, 67020060F
67010010M, 67010060M
67010010A, 67010060A
67010010F, 67010060F
67020010A, 67020060A
67020010M, 67020060M
67020010, 67020060
R G Edwards Cath for EmbryoTransfer
SAGE Vitrification Kit & Warming Kit
SynVitro® Hyadase 15115001
15115001F
15115001D
15115001A
SynVitro® Hyadase 1511
15115001X
Inserter, DMI, Multiple
RECTAL DILATOR
Endosee Advance
Euromed Forceps (multi.)
FP-010 - Fetal Pillow
Global Fertilization
GLOBAL
Embryo Culture and Transfer
LGGG-020, LGGG-050, LGGG-100, LGGF-020, LGGF-050, LGGF-100
LGGG-020M, LGGG-050M, LGGG-100M, LGGF-020M, LGGF-050M, LGGF-100M
DP-M350-CHG1 - Doppler Battery Charger
DP-M350 - Doppler Monitor
DP-MCV01 - Doppler Monitor Cable-Verifier
Apple Pneumo-Matic Insufflation Needle
G03014 - Doppler Long Cuff Probe
DP-SDP002 - Doppler Long Cuff Probe
G21363 - Doppler Probe
DP-SDP001 - Doppler Probe
15135001D
15135001M
SynVitro® Hyadase 1513
15135001A
ORIGIO Sperm Wash 84051010
ORIGIO Gradient 100 84000060
ORIGIO Sperm Wash 84050060
84000060F, 84002060F, 84004125F, 84010060F, 84021210F, 84022010F, 84022060F, 84050060F, 84051010F, 84055060F
84000060A, 84002060A, 84004125A, 84010060A, 84021210A, 84022010A, 84022060A, 84050060A, 84051010A, 84055060A
CCB Density Gradient
ORIGIO® Gradient 90 w/o Gentamicin 84905060 (8490)
ORIGIO Gradient 100
ORIGIO Gradient 90
ORIGIO Gradient 40/80
Sperm Wash
ORIGIO Gradient 40
ORIGIO Gradient 80
ORIGIO Gradient 100 84004125
ORIGIO Sperm Wash 8405
ORIGIO Gradient 40/80 84021210
ORIGIO Gradient 40/80 84022060
ORIGIO Gradient 100 84002060
84000060D, 84002060D, 84004125D, 84010060D, 84021210D, 84022010D, 84022060D, 84050060D, 84051010D, 84055060D
ORIGIO Sperm Wash 84055060
84000060M, 84002060M, 84004125M, 84010060M, 84021210M, 84022010M, 84022060M, 84050060M, 84051010M, 84055060M
ORIGIO Gradient 40/80 84022010
ORIGIO® Gradient 90 w/o Gentamicin 84905060D (8490)
ORIGIO Gradient 90 84010060
SelectMucus
G21364 - Doppler Extension Cable
DP-CAB01 - Doppler Extension Cable
SelectCells Standard [SM200] & Mini [SM203]
Coda
Intrauterine Insemination Catheter
COMFIT Endotracheal Tube Holder
PICSI Dish
SynVitro® Flush 15840125
15840125A
SynVitro® Flush w/o Heparin 15840125
15840125F
SynVitro® Flush without Heparin 15840125
15840125D
EZ-Tip Singles, EZ-Tip vial of 20, EZ-Grip
Water for Tissue Culture (500/1.5L)
ORIGIO - PIPETTES
Stripper TIps
Sperm Select
Oil for Tissue Culture
KOH Colpotomizer System
Irrri-Flo Irrigation Delivery System
H/S Elliptosphere Catheter[61-4005]
CC/Brush [Papette]
Stylet for Embryo Replacement Catheter
10520010, 11520010
10520010F, 11520010F
10520010A, 11520010A
UTM Transfer Medium
10520010M, 11520010M
10520010D, 11520010D
Embryo Thawing Pack 10984010
10264010F, 10984010F
Embryo Freezing pack 10264010
10264010A, 10984010A
10264010D, 10984010D
Embryo Freezing pack 10264010M
Embryo Thawing Pack 10984010M
Artifical Insemination Catheter (Wallace)
QA Serum Protein Substitute
Uterine Dilators [REDA's]
Quinn's Sperm Washing Medium
Fundus Sound
Euromed Sound & Dilator (multi)
Ultimate,Reuse, Plastic Vag.Spec.
NU-TIP SCISSORS
Lone Star Retractors and Stays
Frigitronics CM 73 Cryo System,
Cryo Tips.
Wallach LL CO2 Cryo System, and
C100110 - ONETRAC
C100170 - ONETRAC
C100240 - ONETRAC LX
C100165 - ONETRAC
C100220 - ONETRAC LX
C100190 - ONETRAC
C100280 - ONETRAC LX
C100150 - ONETRAC
C100180 - ONETRAC
C100230 - ONETRAC LX
C100290 - ONETRAC LX
C100140 - ONETRAC
C100260 - ONETRAC LX
C100250 - ONETRAC LX
C100210 - ONETRAC LX
C100270 - ONETRAC LXD
global® Blastocyst Fast Freeze Kit
global® Blastocyst Fast Thawing Kit
LifeGlobal Global HP
Denuding pipettes
Assisted hatching micropipettes
ICSI injection micropipettes
Holding micropipette
HUMI/HUI UterineManipulator/Inject.
TRIA Dopplers
SANI-SCOPE Disposable Anoscope
OPTIK2-05
OPTIK2-04
OPTIK2-11
OPTIK1-03
OPTIK1-01
OPTIK1-02
OPTIK2-03
OPTIK2-05-002
OPTIK2-03-002
OPTIK2-04-002
OPTIK1-00
Leisegang Colposcopes
ORIGIO
Endosee
TPC Pipettes
Endosee Cannula / Hand Tower
Instant Warm Gel Pack
Apple Mobius Retractor for Mini Laparatomy
Trial Transfer Catheter (Wallace)
Incubators
Mars Workstations
Fortuna Workstations
K-Systems Workstations
H/S Catheter Set 61-3005 & 61-3007.
Lapsac - J-LS-081000
Lapsac - J-LS-080500
Lapsac - J-LS-060401
Lapsac - J-LS-050201
VitriGuard
Cervex-Brush
Invitro Maturation Media [IVM]
ALLY II UPS (Uterine Positioning System) Loaner
ALLY II UPS (Uterine Positioning System)
Tampa Catheter [61-2005]
77020003D
77010003M, 77020003M
77010003A
SAGE 1-Step GM-CSF
77010003
77020003A
77020003F
77010003F
77020003
77010003D
Bronchitrac, Bronchitrac "L" Set
MicroDrop GPS Dish
4Well GPS Dish
38 Special GPS Dish
SupraSperm 90
SupraSperm 100
global® DMSO Blastocyst Vitrification Kit
global DMSO Blastocyst Vitrification Warming Kit
16125000M
ICSI Cumulase
ICSI Cumulase 16125000
16125000A
16125000F
16125000D
ICSI Cumulase 1612
MitySoft Extractor Cup Systems
[Disposable]
10670010D
Sperm Freezing Medium
Sperm Freezing Medium 1067
10670010M
10670010F
Sperm Freezing Medium 10670010
10670010A
Select & MiniSpace IUI Catheters [SM400 & SM610]
LEEP Procedure Kit
LM-900 System / Probes
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)