Fabco

FDA UDI

Class I (US FDA UDI)

by First Aid Bandage Co Inc

Identity

Trade Name: FABCO FDA UDI
Generic Name: General-purpose surgical sponge FDA UDI
Model / Reference: 34635010 FDA UDI

Identifiers

Catalog Number: 34635010 FDA UDI
Primary DI / UDI-DI: 30634303020499 FDA UDI
FDA Product Code: GDY FDA UDI
GMDN Term: General-purpose surgical sponge FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4450 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

Yes

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

Dimensions & Sizes

Size: Width — 2 Inch FDA UDI
Length — 5 Yard FDA UDI
Width — 50.8 Millimeter FDA UDI
Length — 4.6 Meter FDA UDI

Category: General-purpose surgical sponge

Fabco by First Aid Bandage Co Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose surgical sponge.

DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Centurion — Centurion Medical Products · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
Dermapac, Inc. — Dermapac Inc. · Class I
A Plus — A PLUS INTERNATIONAL, INC · U
A Plus — A PLUS INTERNATIONAL, INC · U
DeRoyal — DEROYAL INDUSTRIES, INC. · Class I
DeRoyal — DEROYAL INDUSTRIES, INC. · 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: First Aid Bandage Co Inc

Sources (1)

FDA UDI 785b368a-c358-4390-9061-591d010521c2 35 fields · synced May 30, 2026