Insert, Biopsy Punch

Insert, Biopsy Punch
NA - 0250282013

A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

No Data Available

• Length: 20.0 Centimeter
• Outer Diameter: 3.0 Millimeter

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: OCZ

Device Name: Endoscopic Grasping/Cutting Instrument, Non-Powered

Device Class: 2

Physical State: Non-electric and non-magnetic devices. May include: grasping or retrieval forceps, biopsy forceps or other sampling tools, scissors, stone basket, stone dislodger

Definition: To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Place through an endoscope to reach desired area.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: various tissues, stones or other foreign bodies within GI and GU tract.

Regulation Number: 876.1500

Third Party Flag: Y

Medical Specialty: GU

Device Id: 07613327056846

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