638 - Certi-Gauze Compress - 18"x 36" - 2/Unit

FDA UDI

Class U (US FDA UDI)

by Certified Safety Manufacturing, Inc.

Identity

Trade Name: 638 - Certi-Gauze Compress - 18"x 36" - 2/Unit FDA UDI
Generic Name: Non-woven gauze pad FDA UDI
Device Name: 638 - Certi-Gauze Compress - 18"x 36" - 2/Unit FDA UDI
Model / Reference: R211-014 FDA UDI
Description: 638 - Certi-Gauze Compress - 18"x 36" - 2/Unit FDA UDI

Identifiers

Catalog Number: R211-014 FDA UDI
Primary DI / UDI-DI: 00766588110141 FDA UDI
510(k) Number: K960615 FDA UDI
FDA Product Code: EFQ FDA UDI
GMDN Term: Non-woven gauze pad FDA UDI

Classification

Device Class: U 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Non-woven gauze pad

638 - Certi-Gauze Compress - 18"x 36" - 2/Unit by Certified Safety Manufacturing, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K960615 also covers:

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 U	Pending data

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Manufacturer

Manufacturer: Certified Safety Manufacturing, Inc.

Sources (1)

FDA UDI 5cd780b9-6a2d-4d19-aedb-5349bddd6756 36 fields · synced Jun 8, 2026