Identity
- Trade Name
- Biomesh® CA.B.S.’Air® Composite FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, composite-polymer FDA UDI
- Device Name
- The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of an ePTFE and polypropylene plug, two polyethylene terephthalate with biocompatible colorant (D&C Green #6) and ePTFE fixation threads crimped of stainless steel needles. FDA UDI
- Model / Reference
- CABST1R05T FDA UDI
- Description
- The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of an ePTFE and polypropylene plug, two polyethylene terephthalate with biocompatible colorant (D&C Green #6) and ePTFE fixation threads crimped of stainless steel needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760185570374 FDA UDI
- 510(k) Number
- K093196 FDA UDI
- FDA Product Code
- OQL FDA UDIFTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, composite-polymer 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
- Outer Diameter — 50 Millimeter FDA UDI
Category: Extra-gynaecological surgical mesh, composite-polymer
Biomesh® CA.B.S.’Air® Composite by Cousin Biotech Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Extra-gynaecological surgical mesh, composite-polymer.
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- Surgipro — Covidien LP · Class II
Cleared under the same submission
K093196 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 II | Pending data |
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Manufacturer
- Manufacturer
- Cousin Biotech Sas
Sources (1)
- FDA UDI 14a997bb-b7b4-459d-8889-072f3835f3ae 37 fields · synced May 30, 2026