- Physicians Office Resource

Stapler with Polysorb Staples
Roticulator 55 Poly - 013601

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

Handling Environment Temperature - Degrees Fahrenheit

130.00
N/A

Device Sizes

Height: .200 Inch

Length: 55 Millimeter

Height: .200 Inch
Length: 55 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: 20884521047614

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521047617

Package Quantity: 3

Package Discontinue Date: 9/3/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CASE

Device Id: 10884521047617

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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