- Physicians Office Resource

Absorbable Single Stitch Reload
Polysorb - 170070

Device Description

A sterile surgical instrument designed to automatically tie a self-locking, sliding, surgical knot into a delivered suture during open surgery. The knot is subsequently advanced using standard techniques. The instrument is a hand-operated device with an internal mechanism configured to create the knot when the loose ends of the suture are placed into it. This is a single-use device.

Environmental Conditions

Handling Environment Temperature - Degrees Fahrenheit

130.00
N/A

Device Sizes

Length: 7 Inch

diameter,3/0,N/A;

Length: 7 Inch
diameter,3/0,N/A;

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 10884521126770

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884521126777

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 20884521126777

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

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