Gold Marker Set

GUDID 00812444028089

Brachytherapy

RIVERPOINT MEDICAL, LLC

Brachytherapy needle

• Primary Device ID: 00812444028089
• NIH Device Record Key: 5a76f031-9981-49b9-9bac-3247ed4aca48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gold Marker Set
• Version Model Number: FN18-1
• Company DUNS: 964053560
• Company Name: RIVERPOINT MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812444028089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103449

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-05

On-Brand Devices [Gold Marker Set]

• 00812444028324: Brachytherapy
• 00812444028089: Brachytherapy