SPACER

GUDID 00812444024432

BRACHYTHERAPY

RIVERPOINT MEDICAL, LLC

Brachytherapy source spacer

• Primary Device ID: 00812444024432
• NIH Device Record Key: 53eef31b-553f-4deb-9b14-08192bb1bbf8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPACER
• Version Model Number: IAS 910.5.0-50
• 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: true
• 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	00812444024432 [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: 2015-11-17

On-Brand Devices [SPACER]

• 00812444024456: BRACHYTHERAPY
• 00812444024432: BRACHYTHERAPY