Identity
- Trade Name
- 4TR FDA UDI
- Generic Name
- Wound dressing kit, medicated FDA UDI
- Device Name
- Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit FDA UDI
- Model / Reference
- AUXP-4TR FDA UDI
- Description
- Aurix Wound dressing kit single tray with tyvek lidstock label for AGSW-03, 4TR compoonent kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852714003248 FDA UDI
- FDA Product Code
- PMQ FDA UDI
- GMDN Term
- Wound dressing kit, medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wound dressing kit, medicated
4tr by Nuo Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK060007 also covers:
- Aurix Centrifuge — NUO THERAPEUTICS, INC.
- Aurix Eight Pack Kit — NUO THERAPEUTICS, INC.
- Aurix Five Pack Kit — NUO THERAPEUTICS, INC.
- Aurix Reagent Kit — NUO THERAPEUTICS, INC.
- Aurix Single Pack Kit — NUO THERAPEUTICS, INC.
- Aurix Ten Pack Kit — NUO THERAPEUTICS, INC.
- Aurix Wound Dressing Kit — NUO THERAPEUTICS, INC.
- Aurix Wound Dressing Kit — NUO THERAPEUTICS, INC.
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
- Nuo Therapeutics, Inc.
Sources (1)
- FDA UDI 144af523-0f43-4c60-ae46-9ba663bdfe8a 34 fields · synced May 31, 2026