Fixation Device;15 Violet Absorbable Tacks

Fixation Device;15 Violet Absorbable Tacks
AbsorbaTack - ABSTACK15

A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecological, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue during a laparoscopic procedure; it has no cutting function and may be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

• Outer Diameter: 5 Millimeter

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: 20884523006503

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884523006506

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884523006506

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