BRACHYTHERAPY

GUDID 30812444028929

BRACHYTHERAPY

RIVERPOINT MEDICAL, LLC

Brachytherapy needle

• Primary Device ID: 30812444028929
• NIH Device Record Key: 86cbbd00-e190-411b-ace1-e02e34577752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRACHYTHERAPY
• Version Model Number: GM-CKK-1820
• 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	00812444028928 [Primary]
GS1	10812444028925 [Package]; Contains: 00812444028928; Package: [5 Units]; In Commercial Distribution
GS1	20812444028922 [Package]; Contains: 00812444028928; Package: [9 Units]; In Commercial Distribution
GS1	30812444028929 [Package]; Contains: 00812444028928; Package: [10 Units]; In Commercial Distribution

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: 1
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-10-22

On-Brand Devices [BRACHYTHERAPY]

• 30812444028929: BRACHYTHERAPY
• 30812444028875: Brachytherapy needle
• 00812444024975: BRACHYTHERAPY
• 00812444024968: BRACHYTHERAPY
• 00812444024951: BRACHYTHERAPY
• 00812444024944: BRACHYTHERAPY
• 00812444024937: BRACHYTHERAPY
• 30812444028998: Brachytherapy Needle
• 20812444029257: Brachytherapy