Microtek

FDA UDI

Class II (US FDA UDI)

by Microtek Medical LLC

Identity

Trade Name: MICROTEK FDA UDI
Generic Name: Angiographic drape FDA UDI
Device Name: PEDIATRIC ANGIO DRAPE, 1-EACH FDA UDI
Model / Reference: 1 FDA UDI
Description: PEDIATRIC ANGIO DRAPE, 1-EACH FDA UDI

Identifiers

Primary DI / UDI-DI: 00748426070060 FDA UDI
FDA Product Code: KKX FDA UDI
GMDN Term: Angiographic drape 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: Angiographic drape

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

Similar devices

Also classified as Angiographic drape.

Basic Adult EPD Femoral Angio Drape — Argon Medical Devices, Inc. · Class II
Angiography Drape Pack — Argon Medical Devices, Inc. · Class II
Femoral Angio Drape — Argon Medical Devices, Inc. · Class II
Adult EPD Femoral Angio Drape — Argon Medical Devices, Inc. · Class II
Brachial/Axillary/Cerebral Drape — Argon Medical Devices, Inc. · Class II
AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
Medline — MEDLINE INDUSTRIES, 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 7bac80a1-737e-4ec4-8a02-e4c4b8a6c7b7 35 fields · synced Jun 8, 2026