DISPOSABLE GRASPING FORCEPS (BASKET TYPE)


Product Overview

DISPOSABLE GRASPING FORCEPS (BASKET TYPE)
DISPOSABLE GRASPING FORCEPS (BASKET TYPE) - FG-33W


Device Description

A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: FBN

Device Name: Choledochoscope And Accessories, Flexible/Rigid

Device Class: 2

Physical State: endoscope, accessories associated with choledochoscope

Definition: to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: instrument guided laparoscopically or through the esophagus into the biliary tree

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: bile ducts

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU


Device Identifiers

Device Id: 14953170031356

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170031359

Package Quantity: 2

Package Discontinue Date: 6/23/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A


Device Id: 04953170031359

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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