BIOPSY NEEDLE

GUDID 00812444022308

BIOPSY NEEDLE

RIVERPOINT MEDICAL, LLC

Prostate biopsy needle

• Primary Device ID: 00812444022308
• NIH Device Record Key: 72f5a4fb-9555-4a41-ab55-62b017b9756f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPSY NEEDLE
• Version Model Number: RP1000-1820
• 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: 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	00812444022308 [Primary]
GS1	10812444022305 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092059

FDA Product Code

• KNW: Instrument, Biopsy

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: 2015-10-22

On-Brand Devices [BIOPSY NEEDLE]

• 00812444024920: BRACHYTHERAPY
• 00812444024913: BRACHYTHERAPY
• 10812444022954: BIOPSY NEEDLE
• 00812444022926: BIOPSY NEEDLE
• 00812444022308: BIOPSY NEEDLE
• 30812444029148: Biopsy Needle
• 30812444029131: Biopsy Needle