Gold Marker Needle

Basic Information

• Brand Name: Gold Marker Needle
• Primary DI: 00810020085112
• Version / Model: 002051
• Company Name: RIVERPOINT MEDICAL, LLC
• Labeler DUNS: 964053560
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-04
• Public Version: 1
• Public Version Date: 2020-09-14
• Public Version Status: New
• Public Device Record Key: 875bcfa9-e830-4f7a-a950-11000e7e5357

Device Description

Brachytherapy

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXK	Source, Brachytherapy, Radionuclide	Radiology	892.5730	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
Package	10810020085119	GS1		10	In Commercial Distribution
Primary	00810020085112	GS1

Premarket Submissions

Submission Number	Supplement Number
K103449	000