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Microtek

FDA UDI

Class II (US FDA UDI)

by Microtek Medical LLC

Identity

Trade Name
MICROTEK FDA UDI
Generic Name
Instrument/equipment drape, single-use, sterile FDA UDI
Device Name
FLUORO COVER W/TAPE, 28"" X 12"", 1-EACH FDA UDI
Model / Reference
1 FDA UDI
Description
FLUORO COVER W/TAPE, 28"" X 12"", 1-EACH FDA UDI

Identifiers

Primary DI / UDI-DI
00748426016419 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
Instrument/equipment drape, single-use, sterile 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Instrument/equipment drape, single-use, sterile

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

Similar devices

Also classified as Instrument/equipment drape, single-use, sterile.

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 4b8fdb77-030f-45f3-ba58-fb8770334a8f 35 fields · synced Jun 6, 2026