Stapler with Tri
GIA - GIA60TMS
Device Description
A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Length: 60 Millimeter
- 60mm;
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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
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: 20884521842653
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521842656
Package Quantity: 3
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10884521842656
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
