This model includes one of sheath section and six of needle sections. The sheath section is reusable and requires autoclave sterilization prior to use. The needle section is single-use and packaged as sterile. Please refer to the instruction manual for details.

This model includes one of sheath section and six of needle sections. The sheath section is reusable and requires autoclave sterilization prior to use. The needle section is single
ASPIRATION NEEDLE - NA-1C-1

A flexible, sterile, 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 single-use device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: GDM

Device Name: Needle, Aspiration And Injection, Reusable

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

Device Id: 14953170035231

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04953170035234

Package Quantity: 6

Package Discontinue Date: 8/18/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 04953170035234

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