Mesh Positioning System

Mesh Positioning System
AccuMesh - AMPPCO15X

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.

No Data Available

• Outer Diameter: 5.9 Inch

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 10884521174696

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