BRACHYTHERAPY NEEDLE

GUDID 00812444027006

BRACHYTHERAPY

RIVERPOINT MEDICAL, LLC

Brachytherapy needle

• Primary Device ID: 00812444027006
• NIH Device Record Key: a88abc9f-8419-42dd-adbd-d7fa9d981249
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BRACHYTHERAPY NEEDLE
• Version Model Number: GM1033-1812
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812444027006 [Primary]
GS1	10812444027003 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	20812444027000 [Package]; Package: [9 Units]; In Commercial Distribution
GS1	30812444027007 [Package]; 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-28
• Device Publish Date: 2017-08-31

On-Brand Devices [BRACHYTHERAPY NEEDLE]

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