Pak-its®

FDA UDI

Class I (US FDA UDI)

by Derma Sciences Canada, Inc

Identity

Trade Name: Pak-its® FDA UDI
Generic Name: Gauze strip, non-antimicrobial FDA UDI
Device Name: 0.25 in X 36 in 4 ply surgical gauze packing. X-Ray detectable. 28 X24 mesh gauze, cut edges. FDA UDI
Model / Reference: 561036 FDA UDI
Description: 0.25 in X 36 in 4 ply surgical gauze packing. X-Ray detectable. 28 X24 mesh gauze, cut edges. FDA UDI

Identifiers

Catalog Number: DUP561036 FDA UDI
Primary DI / UDI-DI: 00809958053010 FDA UDI
FDA Product Code: GDY FDA UDI
GMDN Term: Gauze strip, non-antimicrobial 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

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Gauze strip, non-antimicrobial

Pak-its® by Derma Sciences Canada, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Gauze strip, non-antimicrobial.

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Bioseal Inc. — BIOSEAL · Class I
Packing Strip — Dynarex Corp. · U
McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
Bioseal Inc. — BIOSEAL · Class I
Dermacea — Cardinal Health 200, LLC · Class I
Bioseal Inc. — BIOSEAL · 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

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Manufacturer

Manufacturer: Derma Sciences Canada, Inc

Sources (1)

FDA UDI 730b9892-934e-4825-bccf-dbe42411b3a9 36 fields · synced May 29, 2026