- Physicians Office Resource

Circular Reload For use with Signia Circular Adapters; Medium/Thick
Tri-Staple 2.0 - SIGCIR25MT

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

Handling Environment Atmospheric Pressure - KiloPascal

101.00
55.00

Handling Environment Humidity - Percent (%) Relative Humidity

90.00
N/A

Handling Environment Temperature - Degrees Fahrenheit

140.00
-20.00

Storage Environment Temperature - Degrees Fahrenheit

94.00
63.00

Device Sizes

Outer Diameter: 25 Millimeter

Outer Diameter: 25 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 Identifiers

Device Id: 20884521703800

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521703803

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PACK_OR_INNER_PACK

Device Id: 10884521703803

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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