Identity
- Trade Name
- ARTIA Reconstructive Tissue Matrix FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- ARTIA Reconstructive Tissue Matrix 10 cm x 16 cm FDA UDI
- Model / Reference
- 10161097 FDA UDI
- Description
- ARTIA Reconstructive Tissue Matrix 10 cm x 16 cm FDA UDI
Identifiers
- Catalog Number
- 10161097 FDA UDI
- Primary DI / UDI-DI
- M328101610970 FDA UDI
- FDA Product Code
- FTM FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDIWidth — 16 Centimeter FDA UDI
Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
ARTIA Reconstructive Tissue Matrix by Lifecell Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial.
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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
- Lifecell Corp
Sources (1)
- FDA UDI c8e54e7a-c366-4ebb-b7d1-cb122651c0c3 37 fields · synced Jun 8, 2026