Duns Number:776742439
Device Description: The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made o 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.
Catalog Number
-
Brand Name
Biomesh® CA.B.S.’Air® Composite
Version/Model Number
CABSAIRC7
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K093196
Product Code
FTL
Product Code Name
Mesh, Surgical, Polymeric
Public Device Record Key
638fe56b-a25c-4e7e-81f0-53a955938d40
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
October 23, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |