Black Extra Thick Circular Reload For use with Signia Circular Adapters

Black Extra Thick Circular Reload For use with Signia Circular Adapters
Tri-Staple 2.0 - SIGCIR28XT

A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) and an internal cutting blade designed to be used with a surgical stapler (not included) during endoscopic or open-surgery (e.g., bowel resection to create anastomoses). The unit is designed to deploy the staples (e.g., in a straight or circular row) while the blade cuts the adjacent tissue. This is a single-use device.

• Outer Diameter: 28 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GAG

Device Name: Stapler, Surgical

Device Class: 2

Physical State: A specialized prescription device that delivers compatible staples to internal tissues.

Definition: A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A specialized prescription device that delivers compatible staples to internal tissues.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Internal tissues.

Regulation Number: 878.4740

Third Party Flag: N

Medical Specialty: HO

Device Id: 20884521703732

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521703735

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PACK_OR_INNER_PACK

Device Id: 10884521703735

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