Biopsy Needle

GUDID 30812444029131

Biopsy Needle

RIVERPOINT MEDICAL, LLC

Brachytherapy needle

• Primary Device ID: 30812444029131
• NIH Device Record Key: e7486318-a4bc-4189-b9d3-64ec590a3447
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biopsy Needle
• Version Model Number: MMC-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: 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	00812444029130 [Primary]
GS1	10812444029137 [Package]; Contains: 00812444029130; Package: [5 Units]; In Commercial Distribution
GS1	20812444029134 [Package]; Contains: 00812444029130; Package: [9 Units]; In Commercial Distribution
GS1	30812444029131 [Package]; Contains: 00812444029130; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-14

On-Brand Devices [Biopsy Needle]

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