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-2C-1
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
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 IdentifiersDevice Id: 14953170035309
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04953170035302
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: 04953170035302
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