3.5-5.0 CM CONTURA CMC w/ TRICONCAVE INTRODUCER

Basic Information

• Brand Name: 3.5-5.0 CM CONTURA CMC w/ TRICONCAVE INTRODUCER
• Primary DI: 15420045505261
• Version / Model: B90012
• Catalog Number: B90012
• Company Name: Hologic, Inc.
• Labeler DUNS: 018925968
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e8af9016-df06-48a9-827d-30946e4eedfa

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JAQ	System, applicator, radionuclide, remote-controlled	Radiology	892.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60421	Breast brachytherapy system applicator, remote-afterloading	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045505261	GS1

Premarket Submissions

Submission Number	Supplement Number
K092323	000