Hemorrhoid and Prolapse Stapler with DST Series Technology

Hemorrhoid and Prolapse Stapler with DST Series Technology
EEA - HEM3335

A sterile, surgical instrument designed to apply surgical staples to tissue in the anal canal to treat haemorrhoids, particularly the procedure for prolapse and haemorrhoids (PPH) [repositioning of the anal canal mucosa to reduce blood flow to internal haemorrhoids]. It is typically pistol-like in design with a rounded, cylindrical head loaded with staples at the distal end, and operating levers at the proximal end intended to deliver a single- or multiple-circular band(s) of staples, whilst cutting away hemorrhoidal tissue. It may include disposable supportive devices intended to assist the procedure (e.g., rectal dilator, anoscope). This is a single-use device.

• Height: 3.5 Millimeter
• Outer Diameter: 33 Millimeter

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

Device Id: 20884521047515

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521047518

Package Quantity: 3

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521047518

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