EleVation™ EV14S

GUDID 10801741182454

EleVation™ Breast Biopsy System Introducer Stylet 14G

Bard Peripheral Vascular, Inc.

Nonimplantable needle guide, single-use

• Primary Device ID: 10801741182454
• NIH Device Record Key: 9e546295-92f4-44c7-947a-df25f0586893
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EleVation™
• Version Model Number: EV14S
• Catalog Number: EV14S
• Company DUNS: 135057938
• Company Name: Bard Peripheral Vascular, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
• 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

• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741182457 [Primary]
GS1	10801741182454 [Package]; Contains: 00801741182457; Package: CA [5 Units]; In Commercial Distribution

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: 2020-09-09
• Device Publish Date: 2020-06-18

On-Brand Devices [EleVation™]

• 10801741182393: EleVation™ Breast Biopsy System Probe 14G
• 10801741182386: EleVation™ Breast Biopsy System Probe 12G
• 10801741182379: EleVation™ Breast Biopsy System Probe 10G
• 10801741182508: EleVation™ Breast Biopsy System Half-Notch Support Cannula 14G
• 10801741182492: EleVation™ Breast Biopsy System Half-Notch Support Cannula 12G
• 10801741182485: EleVation™ Breast Biopsy System Half-Notch Support Cannula 10G
• 10801741182454: EleVation™ Breast Biopsy System Introducer Stylet 14G
• 10801741182447: EleVation™ Breast Biopsy System Introducer Stylet 12G
• 10801741182430: EleVation™ Breast Biopsy System Introducer Stylet 10G
• 10801741182409: EleVation™ Breast Biopsy System Sample Containers