RIVERPONT BRACHYTHERAPY

GUDID 00812444020458

BRACHYTHERAPY

RIVERPOINT MEDICAL, LLC

Brachytherapy needle Brachytherapy needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle Brachytherapy injection needle

• Primary Device ID: 00812444020458
• NIH Device Record Key: 40b88001-ec16-47b2-b5c6-1d20a3b1ee7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RIVERPONT BRACHYTHERAPY
• Version Model Number: 1200-1820-1
• 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	00812444020458 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-21

Devices Manufactured by RIVERPOINT MEDICAL, LLC

• 10812444029441 - HS FIber: 2024-06-26 Suture Tape
• 00810020080285 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080292 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080308 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080315 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080322 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020080360 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button
• 00810020083576 - OrthoButton CL: 2024-05-24 Continuous Loop with Titanium Button