FDA.reportPublic FDA data

Biomesh® CA.B.S.’Air® Composite

Primary DI
03760185570374
Brand
Biomesh® CA.B.S.’Air® Composite
Company
COUSIN BIOTECH
Model
CABST1R05T
Device 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.
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric
OQLMesh, Surgical, Deployment Balloon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
OQLMesh, Surgical, Deployment BalloonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093196000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093196000BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09Cousin Biotech Sas2010-06-25FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760185570374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760185570374037601855703743760185570374

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia surgical mesh, composite-polymerA flat or three-dimensional (3-D), woven/knitted material made of two or more polymers that includes a bioabsorbable polymer [e.g., polyglycolic acid (PGA)] and a non-bioabsorbable polymer [e.g., polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair/reinforcement applications; it is not intended for extra-abdominal applications and not dedicated to diaphragmatic hernia repair. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter50Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00 To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33320144000contact@cousin-biotech.com
+33320144119f.pelletier@cousin-biotech.com

Regulatory Flags#

DUNS number
776742439
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760185576109ResCUBE™RCBCUBETUU2024-01-05
03760185570336Biomesh® CA.B.S.’Air® CompositeCABSAIRC092015-10-23
03760185570343Biomesh® CA.B.S.’Air® CompositeCABSAIRC72015-10-23
03760185570367BIOMESH®CA.B.S.'Air®CABSAIR062015-10-23
03760185570381BIOMESH®CA.B.S.'Air®CABS06P12015-10-23
037601855723234DDOME ®4DDOME24SR2015-10-23
037601855723474DDOME ®4DDOME30SR2015-10-23
037601855723614DDOME ®4DDOME38SR2015-10-23
037601855729274DDOME®4DDOM24GSR2015-10-23
037601855729344DDOME ®4DDOM30GSR2015-10-23
037601855729414DDOME ®4DDOM38GSR2015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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