FDA Registration
Active
🇺🇸 United States
Microtek Medical LLC
Reg #: 3013401749
·
FEI: 3013401749
·
Expires 2026
Products
11
Proprietary Names
65
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Microtek Medical LLC
- Registration Number
- 3013401749
- FEI Number
- 3013401749
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 13000 Deerfield Parkway, Suite 300
- City
- Alpharetta
- State
- GA
- ZIP
- 30004
- Country
- US
Regulatory Submissions
- 510(k) Number
- K201290
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 |
|---|---|---|---|---|---|
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2015-01-13 |
| Warmer, Irrigation Solution | LHC | Class 1 | Physical Medicine | No | 2024-10-09 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2014-10-20 |
| Drape, Patient, Ophthalmic | HMT | Class 2 | General, Plastic Surgery | No | 2024-10-31 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-08-25 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2005-02-01 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2021-04-14 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2021-04-14 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2021-04-14 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2021-04-14 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2021-04-14 |
Proprietary Names
Safety frames / lens
Microtek
Drape Armour
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
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
Ocular Occluder
Eclipse Surgical Drape
Medline Surgical Drape
Medline Keyboard Cover
Medline Band Bag
Medline Set Up Cover
Vari-Lens
Lingeman
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
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 DeNovo 4Pro Electrical Stimulation Device
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility