Brachytherapy Needle

GUDID 10810020082194

Brachytherapy

RIVERPOINT MEDICAL, LLC

Brachytherapy needle

• Primary Device ID: 10810020082194
• NIH Device Record Key: a972270e-ea6f-4224-a0e8-45d452d4a45d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brachytherapy Needle
• Version Model Number: 1105-1815-3
• 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	00810020082197 [Primary]
GS1	10810020082194 [Package]; Contains: 00810020082197; 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: 2019-11-28
• Device Publish Date: 2019-11-20

On-Brand Devices [Brachytherapy Needle]

• 00812444027006: BRACHYTHERAPY
• 00812444026993: BRACHYTHERAPY
• 00812444026399: BRACHYTHERAPY
• 00812444026382: BRACHYTHERAPY
• 30812444029285: Brachytherapy Needle
• 10810020082194: Brachytherapy
• 10810020082187: Brachytherapy