- Physicians Office Resource

Stapler with DST Series Technology
TA - TA6035S

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 application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue; it has no cutting function. The staples 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

Height: 3.5 Millimeter

Length: 60 Millimeter
Height: 3.5 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

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 Identifiers

Device Id: 10884521043213

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

Device Id: 20884521043210

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521043213

Package Quantity: 3

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.