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
Cannula, Manipulator/Injector, Uterine LKF
Holder, Needle, Gastroenterologic FHQ
Speculum, Vaginal, Nonmetal HIB
Cannula, Intrauterine Insemination MFD
Media, Reproductive MQL
Needle, Assisted Reproduction MQE
Calculator, Pulmonary Function Data BZC
Electrocautery, Gynecologic (And Accessories) HGI
Unit, Cryosurgical, Accessories GEH
Catheter, Assisted Reproduction MQF
Instrument, Manual, General Obstetric-Gynecologic KOH
Scissors, General, Surgical LRW
Spatula, Cervical, Cytological HHT
Curette, Surgical, General Use FZS
Unit, Cryotherapy, Ophthalmic HQA
Labware, Assisted Reproduction MQK
Transducer, Ultrasonic, Diagnostic ITX
Monitor, Heart Sound, Fetal, Ultrasonic HEK
Staple, Implantable GDW
Extractor, Vacuum, Fetal HDB
Laparoscope, General & Plastic Surgery GCJ
Powered Laser Surgical Instrument GEX
Culdoscope (And Accessories) HEW
System, Imaging, Pulsed Echo, Ultrasonic IYO
Retractor, Vaginal HDL
Continuous Measurement Thermometer FLL
Brush, Endometrial HFE
Instrument, Surgical, Disposable KDC
Accessory, Assisted Reproduction MQG
Intrauterine Tamponade Balloon OQY
Stapler, Skin QQS
Forceps HTD
Stylet, Surgical, General & Plastic Surgery GAH
Cap, Cervical HDR
Pessary, Vaginal HHW
Punch, Biopsy, Surgical EME
Curette, Suction, Endometrial (And Accessories) HHK
Trocar DRC
Accessory, Assisted Reproduction, Exempt PUB
Semen Analysis Device POV
Aspirator, Endocervical HFC
Needle, Suturing, Disposable GAB
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor PFJ
Colposcope (And Colpomicroscope) HEX
Aspirator, Endometrial HFF
Device, Percutaneous, Biopsy MJG
Instrument, Manual, Specialized Obstetric-Gynecologic KNA
Insufflator, Hysteroscopic HIG
Catheter And Tip, Suction JOL
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories) HES
Electrosurgical, Cutting & Coagulation & Accessories GEI
Surgical Instruments, G-U, Manual (And Accessories) KOA
Ventilator, Non-Continuous (Respirator) BZD
Diaphragm, Contraceptive (And Accessories) HDW
Device, Fixation, Tracheal Tube CBH
Forceps, Biopsy, Gynecological HFB
Monitor, Blood-Flow, Ultrasonic HEP
Monitor, Ultrasonic, Fetal KNG
Infant Heel Warmer (Chemical Heat Pack) MPO
Monitor, Ultrasonic, Nonfetal JAF
Microtools, Assisted Reproduction (Pipettes) MQH
Container, Specimen Mailer And Storage, Non-Sterile NNK
Amniotome HGE
Set, Anesthesia, Paracervical HEE
Pack, Hot Or Cold, Disposable IMD
Tray, Surgical, Instrument FSM
Dilator, Cervical, Fixed Size HDQ
Syringe, Irrigating (Non Dental) KYZ
Laparoscope, Gynecologic (And Accessories) HET
Tube, Smoke Removal, Endoscopic FCZ
Instrument, Manual, Surgical, General Use MDM
Sampler, Endocervical PCF
Tape And Bandage, Adhesive KGX
Scissors, Episiotomy HDK
Scalpel, One-Piece GDX
Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
Support, Breathing Tube JAY
Device, Cystometric, Hydraulic FEN
System, Measurement, Blood-Pressure, Non-Invasive DXN
Retractor GAD
Curette, Uterine HCY
Dilator, Rectal FFP
Cystoscope And Accessories, Flexible/Rigid FAJ
Hysteroscope (And Accessories) HIH
Forceps, General & Plastic Surgery GEN
Fetal Head Elevator PWB
Flowmeter, Blood, Cardiovascular DPW
Transducer, Ultrasonic JOP
Monitor, Fetal Doppler Ultrasound MAA
Pneumoperitoneum Needle FHO
Endoscopic Irrigation/Suction System OCX
Bougie, Urological FAX
Sound, Uterine HHM
Anoscope And Accessories FER
Microtools, Assisted Reproduction (Pipettes), Exempt PUC
Bag, Intestine KGY
Catheters, Suction, Tracheobronchial BSY

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)