Multi-Use Handle

Multi
Tacker - OMS-TTH

A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GDW

Device Name: Staple, Implantable

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 878.4750

Third Party Flag: N

Medical Specialty: SU

Code: OCW

Device Name: Endoscopic Tissue Approximation Device

Device Class: 2

Physical State: may include: delivery instrument, applier, holder, connector, threading tool, needle-loading tool, ring implant, pin implant, knot pusher, sutures, staples, clips, tackers, fasteners

Definition: To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Many methods to perform intended use. Insert instrument through endoscope at desired area of delivery.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Various tissues located within body cavities, hollow organs, and canals in GI and GU tract.

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 20884521070452

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521070455

Package Quantity: 5

Package Discontinue Date: 11/3/2021 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CASE

Device Id: 10884521070455

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