← Back to catalogue

Biomesh® CA.B.S.’Air® Composite

FDA UDI

Class II (US FDA UDI)

by Cousin Biotech Sas

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. - A balloon which allows the deployment of the parietal prosthesis. FDA UDI
Model / Reference
CABSAIRC7 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. - A balloon which allows the deployment of the parietal prosthesis. FDA UDI

Identifiers

Primary DI / UDI-DI
03760185570343 FDA UDI
510(k) Number
K093196 FDA UDI
FDA Product Code
OQL FDA UDI
FTL 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 — 70 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

Similar devices

Also classified as Extra-gynaecological surgical mesh, composite-polymer.

Cleared under the same submission

K093196 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cousin Biotech Sas

Sources (1)

  • FDA UDI 638fe56b-a25c-4e7e-81f0-53a955938d40 37 fields · synced Jun 6, 2026