Identity
- Trade Name
- Packing Strip FDA UDI
- Generic Name
- Gauze strip, non-antimicrobial FDA UDI
- Device Name
- Packing Strip, Plain, Sterile, 1/4" x 5 yd. (6mm x 4.6m) FDA UDI
- Model / Reference
- 3401 FDA UDI
- Description
- Packing Strip, Plain, Sterile, 1/4" x 5 yd. (6mm x 4.6m) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784340128 FDA UDI
- 510(k) Number
- K012816 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Gauze strip, non-antimicrobial 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gauze strip, non-antimicrobial
Packing Strip by Dynarex Corp. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gauze strip, non-antimicrobial.
- Bioseal Inc. — BIOSEAL · Class I
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- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- Derma — Derma Sciences Canada, Inc · Class I
- Pak-Its™ — Derma Sciences Canada, Inc · Class I
- Pak-its® — Derma Sciences Canada, Inc · Class I
- Derma — Derma Sciences Canada, Inc · Class I
Cleared under the same submission
K012816 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
- Dynarex Corp.
Sources (1)
- FDA UDI b8034a59-b3a8-471e-ad8c-82f9dc0f19d6 34 fields · synced Jun 8, 2026