BIOMESH®CA.B.S.'Air®

Basic Information

• Brand Name: BIOMESH®CA.B.S.'Air®
• Primary DI: 03760185570381
• Version / Model: CABS06P1
• Company Name: COUSIN BIOTECH
• Labeler DUNS: 776742439
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-23
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 02aa8746-6560-475f-874c-9eefcd916701

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44756	Extra-gynaecological surgical mesh, composite-polymer	A partially-bioabsorbable, implantable material (e.g., flat sheet) 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 for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760185570381	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K072962	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	68	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: To be stored in a dry place away from light, and at room temperature, in its original packaging Sterilization