- Physicians Office Resource

the Catheter OD is 2.4mm, working length is 2000mm, model of needle is 22, needle extension length is 4 mm, the headend type is metal cap.
NA - AG-5313-2420-2204M

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

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 Identifiers

Device Id: 16959664941611

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 06959664941614

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box

Device Id: 06959664941614

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: 26959664941618

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 16959664941611

Package Quantity: 100

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

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