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Critical Cover

FDA UDI

Class I (US FDA UDI)

by Alphaprotech, Inc.

Identity

Trade Name
Critical Cover FDA UDI
Generic Name
Visitor hygiene coverall FDA UDI
Device Name
Coverall, AlphaGuard, White, Inset Sleeve, Zip Close,Tapered Collar, Elastic Wrist, Ankle & Back, 3XL FDA UDI
Model / Reference
CV-74032-6 FDA UDI
Description
Coverall, AlphaGuard, White, Inset Sleeve, Zip Close,Tapered Collar, Elastic Wrist, Ankle & Back, 3XL FDA UDI

Identifiers

Catalog Number
CV-74032-6 FDA UDI
Primary DI / UDI-DI
10817583022070 FDA UDI
FDA Product Code
LYU FDA UDI
GMDN Term
Visitor hygiene coverall FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4040 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Visitor hygiene coverall

Critical Cover by Alphaprotech, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Visitor hygiene coverall.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphaprotech, Inc.

Sources (1)

  • FDA UDI dce40bfa-1065-44fb-b1c5-95d78409b443 35 fields · synced Jun 8, 2026