Gold Maker

GUDID 30812444026291

Brachytherapy

RIVERPOINT MEDICAL, LLC

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

• 00840277405579 - RootMend™ MRR (Black): 2025-05-09 Adjustable Loop
• 00840277405586 - RootMend™ MRR (Blue): 2025-05-09 Adjustable Loop
• 00840277405593 - RootMend™ MRR: 2025-05-09 Titanium Button
• 00840277405647 - RootMend™ MRR Soft Button (Black): 2025-05-09 Adjustable Loop
• 00840277405654 - RootMend™ MRR Soft Button (Blue): 2025-05-09 Adjustable Loop
• 00840277402196 - PERMACORD™ Stiffened Suture: 2025-05-06 Size 2 Stiffened Suture Blue, UHMWPE Non-absorbable Suture
• 00840277402219 - PERMACORD™ Stiffened Suture: 2025-05-06 Size 2 Stiffened Suture White/Blue, UHMWPE Non-absorbable Suture
• 00840277402233 - PERMALOOP™ MINI Stiffened Suture: 2025-05-06 1.4mm Stiffened Suture Tape w/ Looped End Blue, UHMWPE Non-absorbable Suture