Identity
- Trade Name
- Pak-Its™ FDA UDI
- Generic Name
- Gauze strip, non-antimicrobial FDA UDI
- Device Name
- 2 in X 36 in strung surgical gauze packing. X-Ray detectable. 28 X 24 mesh gauze, cut edges. Sterile. FDA UDI
- Model / Reference
- 4858 FDA UDI
- Description
- 2 in X 36 in strung surgical gauze packing. X-Ray detectable. 28 X 24 mesh gauze, cut edges. Sterile. FDA UDI
Identifiers
- Catalog Number
- DUP4858 FDA UDI
- Primary DI / UDI-DI
- 00809958041222 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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: 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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- 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 533f37d6-4ec7-4605-8bf1-106f9efe0efc 36 fields · synced May 30, 2026