BIOMESH®CA.B.S.'Air®

GUDID 03760185570381

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

COUSIN BIOTECH

Abdominal hernia surgical mesh, composite-polymer
Primary Device ID03760185570381
NIH Device Record Key02aa8746-6560-475f-874c-9eefcd916701
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOMESH®CA.B.S.'Air®
Version Model NumberCABS06P1
Company DUNS776742439
Company NameCOUSIN BIOTECH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com
Phone+33320144000
Emailcontact@cousin-biotech.com

Device Dimensions

Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter
Outer Diameter68 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization
Special Storage Condition, SpecifyBetween 0 and 0 *To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization

Device Identifiers

Device Issuing AgencyDevice ID
GS103760185570381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-10-21
Device Publish Date2015-10-23