Bladeless Optical Fixation Cannula

Bladeless Optical Fixation Cannula
Versaport - ONBFCA5ST

A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the pancreas. It is designed for temporary implantation within the pancreas and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components.

• Outer Diameter: 5 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GCJ

Device Name: Laparoscope, General & Plastic Surgery

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Submission Type ID: 1

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: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 20884521134277

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521134270

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521134270

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