Microtek

FDA UDI

Class II (US FDA UDI)

by Microtek Medical LLC

Identity

Trade Name: MICROTEK FDA UDI
Generic Name: Medical equipment/instrument drape, single-use FDA UDI
Device Name: MICRO DRP FOR LEICA 68MM W/VARI-LENS II GLASS LENS COVER, 1-EACH FDA UDI
Model / Reference: 1 FDA UDI
Description: MICRO DRP FOR LEICA 68MM W/VARI-LENS II GLASS LENS COVER, 1-EACH FDA UDI

Identifiers

Primary DI / UDI-DI: 00748426108954 FDA UDI
FDA Product Code: KKX FDA UDI
GMDN Term: Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Medical equipment/instrument drape, single-use

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

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Also classified as Medical equipment/instrument drape, single-use.

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Probe Cover — Advance Medical Designs, Inc. · Class II
Isoloader Surgical Drape — PROTEK MEDICAL PRODUCTS, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Microtek Medical LLC

Sources (1)

FDA UDI 88a6721b-1ef1-495f-a577-807ba4b5cc81 35 fields · synced Jun 8, 2026