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Medline

FDA UDI

Class I (US FDA UDI)

by Medline Industries, Inc.

Identity

Trade Name
Medline FDA UDI
Generic Name
Radiopaque woven surgical sponge, non-sterile FDA UDI
Device Name
DBD-GAUZE,SPONGE,USP,4"X8",12PLY,NS,XR10 FDA UDI
Model / Reference
DNSCTM25432 FDA UDI
Description
DBD-GAUZE,SPONGE,USP,4"X8",12PLY,NS,XR10 FDA UDI

Identifiers

Catalog Number
DNSCTM25432 FDA UDI
Primary DI / UDI-DI
10884389031629 FDA UDI
FDA Product Code
GDY FDA UDI
GMDN Term
Radiopaque woven surgical sponge, non-sterile 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

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

Yes

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: Radiopaque woven surgical sponge, non-sterile

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

Similar devices

Also classified as Radiopaque woven surgical sponge, non-sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 3b5b11a3-8141-4cee-be83-23826c17478c 35 fields · synced May 30, 2026