ENCOR ENSPIRE® AC4001

GUDID 00801741085956

ENCOR ENSPIRE® Breast Biopsy System Driver Holder

SENORX, INC.

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system

• Primary Device ID: 00801741085956
• NIH Device Record Key: d829f444-d205-4310-ba43-5d87151990b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENCOR ENSPIRE®
• Version Model Number: AC4001
• Catalog Number: AC4001
• 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: true
• Serial Number: false
• 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	00801741085956 [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 ENSPIRE®]

• 00801741086113: ENCOR ENSPIRE® Breast Biopsy System
• 10801741086103: ENCOR ENSPIRE® Breast Biopsy System Vacuum Tubing Cassette
• 10801741086097: ENCOR ENSPIRE® Breast Biopsy System Vacuum and Rinse Tubing Cassette
• 00801741085956: ENCOR ENSPIRE® Breast Biopsy System Driver Holder