EnCor ENCFNGUIDE01

GUDID 00801741086496

EnCor Breast Biopsy System Needle Guide (Fischer) For use with Fischer Stereotactic Imaging Tables

SENORX, INC.

Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system Mammographic stereotactic biopsy system

• Primary Device ID: 00801741086496
• NIH Device Record Key: 499a7730-e690-48a2-b0c4-466a7691e7b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnCor
• Version Model Number: ENCFNGUIDE01
• Catalog Number: ENCFNGUIDE01
• 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@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com
• Phone: +1(800)321-4254
• Email: medical.services@BD.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741086496 [Primary]

FDA Product Code

• KNW: Instrument, biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-23
• Device Publish Date: 2024-04-15

Devices Manufactured by SENORX, INC.

• 00801741086496 - EnCor: 2024-04-23EnCor Breast Biopsy System Needle Guide (Fischer) For use with Fischer Stereotactic Imaging Tables
• 00801741086496 - EnCor: 2024-04-23 EnCor Breast Biopsy System Needle Guide (Fischer) For use with Fischer Stereotactic Imaging Tables
• 00801741086731 - ENCOR®: 2018-10-25 ENCOR® Breast Biopsy System Vacuum Package
• 00801741085956 - ENCOR ENSPIRE®: 2018-09-24 ENCOR ENSPIRE® Breast Biopsy System Driver Holder
• 00801741086052 - ENCOR®: 2018-09-24 ENCOR® Breast Biopsy System Control Module
• 00801741086076 - ENCOR®: 2018-09-24 ENCOR® Breast Biopsy System Driver
• 00801741086083 - ENCOR®: 2018-09-24 ENCOR® Breast Biopsy System MRI Driver
• 00801741086113 - ENCOR ENSPIRE®: 2018-09-24 ENCOR ENSPIRE® Breast Biopsy System
• 00801741086137 - ENCOR ULTRA®: 2018-09-24 ENCOR ULTRA® Breast Biopsy System