Circular Stapler with DST Series Technology

Circular Stapler with DST Series Technology
EEA - EEAXL2535

A sterile, hand-held, manual surgical instrument intended to be used during open or laparoscopic surgical procedures of the alimentary tract, to create anastomoses (e.g., end-to-end, end-to-side, or side-to-side) via intraluminal (within the lumen) resection. It is designed to connect two portions of lumen (e.g., colon) with a single or multiple circular rows of staples, and then cut out the tissue within the staple line to create a new channel. This device operates via a manual lever mechanism and may be available in a variety of sizes appropriate to a specific luminal diameter. This is a single-use device.

• Outer Diameter: 25 Millimeter
• Height: 3.5 Millimeter
• Length,XL,N/A;

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 20884523006121

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884523006124

Package Quantity: 3

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884523006124

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