Titanium needle 113mm, 17 gauge, trocar point

Basic Information

• Brand Name: Titanium needle 113mm, 17 gauge, trocar point
• Primary DI: 00816389029293
• Version / Model: GM11009700
• Catalog Number: GM11009700
• 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: 2021-12-09
• Public Version: 1
• Public Version Date: 2021-12-17
• Public Version Status: New
• Public Device Record Key: 7afd413e-af1d-468c-8411-32689cf587f0

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 Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
33069	Brachytherapy needle	A sterile, sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816389029293	GS1

Premarket Submissions

Submission Number	Supplement Number
K093291	000