cousin-biotech.comCortical Fixation Systems
Cousin Biotech S.A.S.
Cousin Biotech
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9616062 | 3003258310 | Cousin Biotech | 1 | N | 2026-01-01 | ALLEE DES ROSES WERVICQ-SUD Nord FR 59117 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03760185570336 | Biomesh® CA.B.S.’Air® Composite - The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of an ePTFE and polypropylene plug, four 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. | +33320144000 | contact@cousin-biotech.com |
| 03760185570336 | Biomesh® CA.B.S.’Air® Composite - The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of an ePTFE and polypropylene plug, four 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. | +33320144119 | f.pelletier@cousin-biotech.com |
| 03760185570343 | Biomesh® CA.B.S.’Air® Composite - 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. | +33320144000 | contact@cousin-biotech.com |
| 03760185570343 | Biomesh® CA.B.S.’Air® Composite - 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. | +33320144119 | f.pelletier@cousin-biotech.com |
| 03760185570367 | BIOMESH®CA.B.S.'Air® - The BIOMESH® CA.B.S.'Air® prosthesis consists of (according to the references on the box): - A parietal prosthesis made of a plug and a polypropylene mesh and two polyethylene terephthalate and ePTFE fixation threads crimped of stainless steel needles. - A balloon which allows the deployment of the parietal prosthesis | +33320144000 | contact@cousin-biotech.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 58386 | 1425153176 | K181799 | ResCUBE™ Ligament Fixation System | OWI | 2018-08-29 |
| 58386 | 1384427113 | K093196 | BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09 | FTL | 2010-06-25 |
| 58386 | 1088889310 | K072962 | CABS'AIR | FTL | 2008-06-26 |
| 58386 | 1496184843 | K070918 | 4DDOME | FTL | 2007-08-22 |
| 58386 | 1007615411 | ||||
| 58386 | 1154133605 | ||||
| 58386 | 1310197987 | ||||
| 58386 | 1405629283 | ||||
| 58386 | 1740278365 | ||||
| 58386 | 1802091990 | ||||
| 58386 | 1894131007 | ||||
| 58386 | 2002621993 |
Product Codes Associated With Registrations#
PMN#
ResCUBE™ Ligament Fixation System
Cousin Biotech S.A.S.
NAJA™ Ligament Correction System
Cousin Biotech S.A.S.
PREMIUM
COUSIN BIOTECH S.A.S.
BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09
COUSIN BIOTECH S.A.S.
CABS'AIR
COUSIN BIOTECH S.A.S.
4DDOME
COUSIN BIOTECH
BIOMESH P1 AND BIOMESH PLUG AND PATCH
COUSIN BIOTECH S.A.R.L
GUDID#
ResCUBE™ - The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. It consists of: - A ligament allowing correction and stabilization of the levels, after tensioning - A malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath. The lamella and shrink sleeve are not intended for long term implantation and must be removed after placement of the implant. - A low-profile connector holding the tension on the ligament
2024-01-05
Biomesh® CA.B.S.’Air® Composite - The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of an ePTFE and polypropylene plug, four 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.
2015-10-23
Biomesh® CA.B.S.’Air® Composite - 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.
2015-10-23
BIOMESH®CA.B.S.'Air® - The BIOMESH® CA.B.S.'Air® prosthesis consists of (according to the references on the box): - A parietal prosthesis made of a plug and a polypropylene mesh and two polyethylene terephthalate and ePTFE fixation threads crimped of stainless steel needles. - A balloon which allows the deployment of the parietal prosthesis
2015-10-23
Biomesh® CA.B.S.’Air® Composite - 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.
2015-10-23
BIOMESH®CA.B.S.'Air® - The BIOMESH® CA.B.S.'Air® prosthesis consists of (according to the references on the box): - A parietal prosthesis made of a plug and a polypropylene mesh and two polyethylene terephthalate and ePTFE fixation threads crimped of stainless steel needles. - A balloon which allows the deployment of the parietal prosthesis
2015-10-23
4DDOME ® - The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.
2015-10-23
4DDOME ® - The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.
2015-10-23
4DDOME ® - The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.
2015-10-23
4DDOME® - The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.
2015-10-23
4DDOME ® - The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.
2015-10-23
4DDOME ® - The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.
2015-10-23