Circular Reload For use with Signia Circular Adapters; Medium/Thick
Tri-Staple 2.0 - SIGCIR21MT
Device Description
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.
Environmental Conditions
- 101.00
- 55.00
- 90.00
- N/A
- 140.00
- -20.00
- 94.00
- 63.00
Device Sizes
- Outer Diameter: 21 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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
Device IdentifiersDevice Id: 20884521703787
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521703780
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK
Device Id: 10884521703780
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