FDA Registration
Active
🇺🇸 United States
Microtek Medical LLC
Reg #: 3021970868
·
FEI: 3021970868
·
Expires 2026
Products
18
Proprietary Names
96
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- Microtek Medical LLC
- Registration Number
- 3021970868
- FEI Number
- 3021970868
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 990 Lone Oak Road, Suite 130
- City
- Eagan
- State
- MN
- ZIP
- 55121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K811268
Owner / Operator
- Firm Name
- Medline Industries, LP
- Operator Number
- 1417592
- Address
- Three Lakes Drive
- City
- Northfield
- State
- IL
- Postal Code
- 60093
- Country
- US
- Correspondent
- Stephanie Augsburg
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2024-10-30 |
| Urinal | FNP | Class 1 | General Hospital | No | 1991-12-30 |
| Drape, Patient, Ophthalmic | HMT | Class 2 | General, Plastic Surgery | No | 2024-10-31 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2014-10-20 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2024-10-30 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2005-02-01 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2018-03-22 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2005-02-01 |
| Bag, Intestine | KGY | Class 1 | General, Plastic Surgery | No | 2024-10-30 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2014-10-16 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2016-01-13 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2005-02-01 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-25 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2015-01-13 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2024-10-30 |
| Drape, Urological, Disposable | EYY | Class 2 | General, Plastic Surgery | No | 2024-10-30 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2005-02-01 |
| Warmer, Irrigation Solution | LHC | Class 1 | Physical Medicine | No | 2024-10-09 |
Proprietary Names
Microtek
Transfer Bottle
Collection Bottle
Medline Urinal
Ocular Occluder
Protection Plus Disposable Underpads
Medline Disposable Underpads
FitRight
Ultrasorb, Extrasorb, Therasorb, Drypad, Underpads
OREX MEDICAL BEDDING
DISPOSABLE BEDDING
CleanOp: bedding and cleaning supplies
Microtek Disposable Baby Blanket
Extrasorb
MICROTEK DISPOSABLE BEDDING
FitRight Extended Use Underpad
BEDDING
Ultrasorb
MEDICAL GENERAL HOSPITAL
ComfortGlide Drypad
DePuy
Unna
Medline Elastic Bandage
Unna-Z
CURAD
Threeflex
Bandages
Fourflex
Medline Elastic Retention Netting
CoFlex LF2
Medline Stockinette
CoFlex
Sure-Wrap Elastic Bandage
ACCU-SORB
Matrix
Esmark
TwoFlex
Accu-Wrap
Medline Light Handle Cover
BERMAN AIRWAYS
MEDLINE AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY - CAE
DYNACOR AIRWAYS
"Salt Airway S.A.L.T."
VARIOUS SIZES DYNACOR AIRWAYS
Medline Hard Guedel Airway
Intestine Bag
Microtek Intestine Bag
Medline Silicone Bulb Evacuator for Closed Wound Drainage
Medline Evacuator Kit
Wound Evac
Medline Wound Drain Kit
Remote Control Drape
Lingeman
Medline 5-in-1 connector
Medline Connecting Tubing
MEDLINE TUBE, ASPIRATING, FLEXIBLE, CONNECTING - BYY
DYNACOR SUCTION CONNECTING TUBING
Eclipse Surgical Drape
Medline Surgical Drape
Medline Keyboard Cover
Medline Band Bag
Medline Set Up Cover
Vari-Lens
Procept
AKTORmed
Microtek Patient Drapes
Medline Dome Bag
Convertors
Vital Care
Perfect Pouch
OnLume
Medline Poly-lined Drape
Medline Poly-lined Fenestrated Drape
Medline Equipment Cover
Microtek Probe Cover
Microtek Equipment Drapes
Safety frames / lens
Drape Armour
Misonix Irrigation Tube Set
Lithotomy Drape
Medline / Konig Catheter and Tip, Suction
SUCTION CATHETERS
DYNACOR - POOLE SUCTION TIP
Ortho
YANKAUER SUCTIONING INSTRUMENTS
MEDLINE CATHETER AND TIP, SUCTION - JOL
STERILE PHYSIOLOGICAL SALINE
STERILE WATER
Hush-Slush Consoles
Fluid Warming and Surgical Slush
IntraTemp Fluid Warming System
CoreTemp Surgical Solution Warming System
ORS Solution Warmers
Ecolab Fluid Warmer
Titan Series
IntraTemp ThermaBasin
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device