the Catheter OD is 2.4mm, working length is 1600mm, model of needle is 22, needle extension length is 4 mm, the headend type is metal cap.
NA - AG-5313-2416-2204M
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
- model of needle, needle extension length
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 16959664941604
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 06959664941607
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: 06959664941607
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
Device Id: 26959664941601
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 16959664941604
Package Quantity: 100
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton