Identity
- Trade Name
- carePAC FDA UDI
- Generic Name
- Wound dressing kit, medicated FDA UDI
- Device Name
- carePAC Large Size, Collagen XL Matrix w/ Bordered Fiber Gelling Gauze Kit contains: CP003 - 7x7 Collagen Matrix with Primary DI: 30612553024290 or 00366977377775 CP007 - Fiber Gell Dressing 7x7 with Primary DI: 4052199515175 OR CP008 - 8x8 Bordered with Primary DI: 4052199580494 CP010 - Conforming Stretch Bandage 6inx4.1yds with Primary DI: 10612553016239 or 10612553013238 CP000 - Gloves FDA UDI
- Model / Reference
- CX-MB01 FDA UDI
- Description
- carePAC Large Size, Collagen XL Matrix w/ Bordered Fiber Gelling Gauze Kit contains: CP003 - 7x7 Collagen Matrix with Primary DI: 30612553024290 or 00366977377775 CP007 - Fiber Gell Dressing 7x7 with Primary DI: 4052199515175 OR CP008 - 8x8 Bordered with Primary DI: 4052199580494 CP010 - Conforming Stretch Bandage 6inx4.1yds with Primary DI: 10612553016239 or 10612553013238 CP000 - Gloves FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850003042473 FDA UDI
- FDA Product Code
- MCY FDA UDI
- GMDN Term
- Wound dressing kit, medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5075 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound dressing kit, medicated
carePAC by Extremity Care, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Extremity Care, Llc
Sources (1)
- FDA UDI 844724e5-7e0d-4455-b06f-7de9d621f6c8 35 fields · synced May 30, 2026