ENCOR ULTRA® E5115

GUDID 00801741086137

ENCOR ULTRA® Breast Biopsy System

SENORX, INC.

Mammographic stereotactic biopsy system

• Primary Device ID: 00801741086137
• NIH Device Record Key: 41cc6538-30fd-45d2-82e3-58f464e86cde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENCOR ULTRA®
• Version Model Number: E5115
• Catalog Number: E5115
• Company DUNS: 043674543
• Company Name: SENORX, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741086137 [Primary]

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: 3
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-09-20

On-Brand Devices [ENCOR ULTRA®]

• 10801741086721: ENCOR ULTRA® Breast Biopsy System Vacuum Tubing
• 00801741086137: ENCOR ULTRA® Breast Biopsy System