FINESSE® F14105US

GUDID 10801741085168

FINESSE® Ultra 14 Breast Biopsy Probe, 14G x 105mm

Bard Peripheral Vascular, Inc.

Soft-tissue biopsy needle, single-use

• Primary Device ID: 10801741085168
• NIH Device Record Key: 4557ff4c-b9ff-41ba-a58a-0128938982da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FINESSE®
• Version Model Number: F14105US
• Catalog Number: F14105US
• 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: 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: true
• 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
• 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
• 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 Dimensions

• Length: 105 Millimeter
• Length: 105 Millimeter
• Length: 105 Millimeter
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter
• Needle Gauge: 14 Gauge
• Length: 105 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741085161 [Primary]
GS1	10801741085168 [Package]; Contains: 00801741085161; Package: CA [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093068

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: 2
• Public Version Date: 2018-03-29
• 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