Pak-its®

FDA UDI

Class II (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: 2 in X 5 yards gauze packing iodoform strip in bottles with dispenser insert. FDA UDI
Model / Reference: 59445 FDA UDI
Description: 2 in X 5 yards gauze packing iodoform strip in bottles with dispenser insert. FDA UDI

Identifiers

Catalog Number: DUP59445 FDA UDI
Primary DI / UDI-DI: 10381780491941 FDA UDI
FDA Product Code: FER FDA UDI
GMDN Term: Gauze strip, non-antimicrobial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Gauze strip, non-antimicrobial

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

Similar devices

Also classified as Gauze strip, non-antimicrobial.

Bioseal Inc. — BIOSEAL · Class I
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 II	Pending data

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Manufacturer

Manufacturer: Derma Sciences Canada, Inc

Sources (1)

FDA UDI fcc33e82-ca43-4d41-9203-338d26a20479 36 fields · synced May 30, 2026