Medline Industries, Inc.

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name: MEDLINE INDUSTRIES, INC. FDA UDI
Generic Name: Woven gauze pad, non-antimicrobial FDA UDI
Device Name: GAUZE,SPONGE,2"X2",12PLY,STERILE,LF FDA UDI
Model / Reference: PRM21419B FDA UDI
Description: GAUZE,SPONGE,2"X2",12PLY,STERILE,LF FDA UDI

Identifiers

Catalog Number: PRM21419B FDA UDI
Primary DI / UDI-DI: 10884389105603 FDA UDI
FDA Product Code: GDY FDA UDI
NAB FDA UDI
GMDN Term: Woven gauze pad, non-antimicrobial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4450 FDA UDI
878.4014 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 2 Inch FDA UDI
Length — 2 Inch FDA UDI

Category: Woven gauze pad, non-antimicrobial

Medline Industries, Inc. by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Woven gauze pad, non-antimicrobial.

AMD-RITMED ALL GAUZE — AMD Medicom Inc · Class I
HCS — Concordance Healthcare Solutions LLC · Class I
AMD-RITMED ALL GAUZE — AMD Medicom Inc · Class I
MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I
Dermacea — Cardinalhealth · Class I
Dealmed — DEALMED MEDICAL SUPPLIES LLC · Class I
AMD-RITMED ALL GAUZE — AMD Medicom Inc · Class I
Kerlix — Cardinalhealth · 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: Medline Industries, Inc.

Sources (1)

FDA UDI 4773d7c9-8a6d-4e4f-b8d6-cb11437ab85e 36 fields · synced May 30, 2026