Applicator probe, 6.3 mm diameter x 320 mm, straight, 80 mm

Basic Information

• Brand Name: Applicator probe, 6.3 mm diameter x 320 mm, straight, 80 mm
• Primary DI: 00816389026322
• Version / Model: GM11011660
• Catalog Number: GM11011660
• Company Name: Varian Medical Systems Deutschland GmbH
• Labeler DUNS: 332474605
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9cb71cba-427a-41ac-af79-8faac58f2525

Device Characteristics

• Single Use: No
• 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: 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
38407	Vaginal brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in vaginal or transvaginal radiation therapy treatments. It is designed for temporary implantation within the body and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the vaginal area. This GMDN code includes a variety of applicators, e.g., hollow needles or tubes and catheters, and their associated components.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816389026322	GS1

Premarket Submissions

Submission Number	Supplement Number
K160516	000