4.0
4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER - B11245
Device Description
A sterile, remote-afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the breast. It is typically designed for temporary implantation within the breast and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. Included are various types of applicators such as hollow needles, tubes, or catheters, and their associated components. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: JAQ
Device Name: System, Applicator, Radionuclide, Remote-Controlled
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: RA
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: 892.5700
Third Party Flag: N
Medical Specialty: RA
Device IdentifiersDevice Id: 15420045505193
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: 25420045505190
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15420045505193
Package Quantity: 1
Package Discontinue Date: 8/15/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: BOX