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

• 10810020085225 - HS Fiber: 2024-08-15 Suture Tape
• 10810020083672 - HS Fiber: 2024-08-08 Suture
• 00840277404756 - Iconix: 2024-08-05 Iconix Knotless, 1.4mm Anchor with XBraid™ S (Blue/Black/White)
• 00840277404763 - Iconix: 2024-08-05 Iconix Knotless, 2.3mm Anchor with #2 XBraid S (Blue/Black)
• 10812444029441 - HS FIber: 2024-06-26 Suture Tape
• 00810020080285 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080292 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080308 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button