FINESSE® F01BLU

GUDID 00801741085147

FINESSE® Ultra Breast Biopsy System

Bard Peripheral Vascular, Inc.

Side-notch biopsy gun, reusable Side-notch biopsy gun, reusable Side-notch biopsy gun needle Side-notch biopsy gun needle Side-notch biopsy gun needle Side-notch biopsy gun needle Side-notch biopsy gun needle Side-notch biopsy gun needle Side-notch biopsy gun needle Side-notch biopsy gun needle Side-notch biopsy gun needle Side-notch biopsy gun needle Side-notch biopsy gun needle

• Primary Device ID: 00801741085147
• NIH Device Record Key: 893945e0-8da5-4474-bbe9-57cb295d6e73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FINESSE®
• Version Model Number: F01BLU
• Catalog Number: F01BLU
• Company DUNS: 135057938
• Company Name: Bard Peripheral Vascular, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741085147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103359

FDA Product Code

• KNW: INSTRUMENT, BIOPSY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-09-20

On-Brand Devices [FINESSE®]

• 10801741085168: FINESSE® Ultra 14 Breast Biopsy Probe, 14G x 105mm
• 00801741085147: FINESSE® Ultra Breast Biopsy System
• 10801741083935: FINESSE® Ultra Introducer Stylet, 14G x 105mm
• 10801741083928: FINESSE® Ultra Introducer Stylet, 10G x 105mm