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Microtek

FDA UDI

Class II (US FDA UDI)

by Microtek Medical LLC

Identity

Trade Name
MICROTEK FDA UDI
Generic Name
Single-chamber venous compression system garment, single-use FDA UDI
Device Name
"COMFORT LINED SLEEVES,EX LG,14""LONG, N/S, (5 PAIR)" FDA UDI
Model / Reference
1 FDA UDI
Description
"COMFORT LINED SLEEVES,EX LG,14""LONG, N/S, (5 PAIR)" FDA UDI

Identifiers

Primary DI / UDI-DI
00748426112555 FDA UDI
510(k) Number
K001802 FDA UDI
FDA Product Code
JOW FDA UDI
GMDN Term
Single-chamber venous compression system garment, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Single-chamber venous compression system garment, single-use

Microtek by Microtek Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-chamber venous compression system garment, single-use.

Cleared under the same submission

K001802 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microtek Medical LLC

Sources (1)

  • FDA UDI cdab6626-f43f-4735-b4df-2755c25f5814 36 fields · synced Jun 8, 2026