EnCor ENCFNGUIDE01

GUDID 00801741086496

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

SENORX, INC.

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