Gold Maker

GUDID 30812444026291

Brachytherapy

RIVERPOINT MEDICAL, LLC

Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant

• Primary Device ID: 30812444026291
• NIH Device Record Key: f76c9ef0-01cf-418f-af66-e8f1264553b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gold Maker
• Version Model Number: GM1054
• 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: true
• 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	00812444026290 [Primary]
GS1	30812444026291 [Package]; Contains: 00812444026290; Package: [10 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-13
• Device Publish Date: 2018-07-11

Devices Manufactured by RIVERPOINT MEDICAL, LLC

• 00810020080049 - MedLED Chrome: 2024-04-25 MC3 Hospital Kit Accessories
• 00810020080278 - MedLED Chrome: 2024-04-25 Chrome® Headstrap Soft-Top Assembly
• 00810020080407 - MedLED Chrome: 2024-04-25 MC3 HT Hospital Kit Incl Headlamp Assembly, Carry Case
• 00810020080483 - MedLED Chrome: 2024-04-25 DEMO - MC3/6/7 Hospital Kit
• 00810020080490 - MedLED Chrome: 2024-04-25 MC3/6/7 HT Std Kit Incl Headlamp Assembly, Carry
• 00810020085815 - MedLED Spectra: 2024-04-25 Rechargeable Battery Set (1 pc.)
• 00810020086034 - MedLED Face Shield: 2024-04-25 GOV - Shield & Mounting Kit
• 00810020086683 - MedLED Spectra: 2024-04-25 MG8 Bezel System Assembly