Applicator Needle

GUDID 00812444027310

Brachytherapy

RIVERPOINT MEDICAL, LLC

Brachytherapy needle Brachytherapy needle

• Primary Device ID: 00812444027310
• NIH Device Record Key: 8a0988cb-59b5-4e6d-ac26-40e0613f8953
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Applicator Needle
• Version Model Number: 1100-1812X
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812444027310 [Primary]
GS1	10812444027317 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	20812444027314 [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: 2019-05-24
• Device Publish Date: 2017-11-02

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