Vaginal Applicator Set with CT Cylinders

Basic Information

• Brand Name: Vaginal Applicator Set with CT Cylinders
• Primary DI: 00816389022997
• Version / Model: GM11004140
• Company Name: Varian Medical Systems Deutschland GmbH
• Labeler DUNS: 332474605
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2020-12-01
• Public Version Status: Update
• Public Device Record Key: bec25292-3073-4b8f-a3be-84498f59524b
• Distribution End Date: 2019-09-19

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• 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: Moist Heat or Steam 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
38417	Tongue brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the tongue or oral cavity. It is typically designed for temporary implantation within the tongue and/or the tissue surrounding the tongue and serves 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816389022997	GS1

Premarket Submissions

Submission Number	Supplement Number
K033371	000