GOLD MARKER

GUDID 00812444025842

BRACHYTHERAPY

RIVERPOINT MEDICAL, LLC

Manual brachytherapy source, permanent implant

• Primary Device ID: 00812444025842
• NIH Device Record Key: 8ce670a5-1b56-4f1b-9919-c7964dac7fd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GOLD MARKER
• Version Model Number: GM1053
• Company DUNS: 964053560
• Company Name: RIVERPOINT MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812444025842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103449

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-17

On-Brand Devices [GOLD MARKER]

• 10812444028826: Gold Marker
• 30812444027991: GM1254
• 30812444027977: Brachytherapy
• 00812444027136: BRACHYTHERAPY
• 00812444025842: BRACHYTHERAPY
• 00812444024739: BRACHYTHERAPY
• 00812444024449: BRACHYTHERAPY
• 00812444023527: BRACHYTHERAPY
• 00812444023510: BRACHYTHERAPY
• 00812444023282: BRACHYTHERAPY
• 00812444023275: BRACHYTHERAPY
• 00812444022209: Brachytherapy
• 00812444022049: SUTURE
• 10810020083146: Brachytherapy
• 10810020083139: Brachytherapy