GCB Medical Supply

FDA UDI

Class I (US FDA UDI)

by Gcb Medical Llc

Identity

Trade Name: GCB Medical Supply FDA UDI
Generic Name: Shoe cover FDA UDI
Device Name: GCB MEDICAL BOOT COVER UNIVERSAL FDA UDI
Model / Reference: GCB2211 FDA UDI
Description: GCB MEDICAL BOOT COVER UNIVERSAL FDA UDI

Identifiers

Catalog Number: GCB2211 FDA UDI
Primary DI / UDI-DI: 00810184641070 FDA UDI
FDA Product Code: BWP FDA UDI
FXP FDA UDI
GMDN Term: Shoe cover 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

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Shoe cover

GCB Medical Supply by Gcb Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shoe cover.

Halyard — O&M HALYARD, INC. · Class I
Halyard — O&M HALYARD, INC. · Class I
Critical Cover — ALPHAPROTECH, INC. · Class I
PremierPro — SVS LLC · Class I
Critical Cover — ALPHAPROTECH, INC. · Class I
Critical Cover — ALPHAPROTECH, INC. · Class I
PRO ADVANTAGE — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Gcb Medical Llc

Sources (1)

FDA UDI 955b43c8-0405-4eea-ad8f-b62780ea646d 35 fields · synced May 30, 2026