Bioinductive Implant with Arthroscopic Delivery System - Medium

Bioinductive Implant with Arthroscopic Delivery System - Medium - 4397

A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OWY

Device Name: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Device Class: 2

Physical State: A collagen mesh; either square, rectangular, round or of various other shapes.

Definition: For reinforcement of soft tissue where weakness exists in tendon repair.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A collagen mesh that reinforces soft tissue.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Tendon

Regulation Number: 878.3300

Third Party Flag: N

Medical Specialty: SU

Code: ORQ

Device Name: Mesh, Surgical, Deployer

Device Class: 2

Physical State: manual laparoscopic surgical instrument ;operation handle and deployment section.

Definition: Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: intended to facilitate hernia mesh delivery and placement during laparoscopic ventral hernia repair.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: abdominal cavity

Regulation Number: 878.3300

Third Party Flag: N

Medical Specialty: SU

Device Id: 00854501006142

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A