Sheath section

Sheath section - MAJ-69

A flexible sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: GAA

Device Name: Needle, Aspiration And Injection, Disposable

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: N

Target Area: N/A

Regulation Number: 878.4800

Third Party Flag: N

Medical Specialty: SU

Code: FBK

Device Name: Endoscopic Injection Needle, Gastroenterology-Urology

Device Class: 2

Physical State: needle and accessories to needle. does not include pneumoperitoneum needles

Definition: inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: instrument guided through endoscope to puncture desired tissue

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: gi and gu tissues

Regulation Number: 876.1500

Third Party Flag: Y

Medical Specialty: GU

Device Id: 04953170033971

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