Brachytherapy Needle

GUDID 30812444029285

Brachytherapy Needle

RIVERPOINT MEDICAL, LLC

Brachytherapy needle

• Primary Device ID: 30812444029285
• NIH Device Record Key: 03b8a380-7b35-4c82-a859-fbe830eee11d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brachytherapy Needle
• Version Model Number: GM0832-SS20-1820
• 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	00812444029284 [Primary]
GS1	10812444029281 [Package]; Contains: 00812444029284; Package: [5 Units]; In Commercial Distribution
GS1	20812444029288 [Package]; Contains: 00812444029284; Package: [9 Units]; In Commercial Distribution
GS1	30812444029285 [Package]; Contains: 00812444029284; 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: 2019-04-24
• Device Publish Date: 2019-04-16

On-Brand Devices [Brachytherapy Needle]

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