FG-19SX-1B FLEXCYSTO BASKET FORCEP ONLY

FG
GRASPING FORCEPS - FG-19SX-1

A flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). It is typically designed with a long, thin, flexible body that has an expandable basket at the distal end in which objects are caught for extraction. This is a reusable device.

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No Data Available

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: 14953170031967

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170031960

Package Quantity: 1

Package Discontinue Date: 8/10/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 04953170031960

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