ENCOR ENSPIRE® DS4001

GUDID 10801741086097

ENCOR ENSPIRE® Breast Biopsy System Vacuum and Rinse Tubing Cassette

SENORX, INC.

Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 10801741086097
• NIH Device Record Key: 7bb81452-29e9-430f-8e65-46f375c46796
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENCOR ENSPIRE®
• Version Model Number: DS4001
• Catalog Number: DS4001
• 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: 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: 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	00801741086090 [Primary]
GS1	10801741086097 [Package]; Contains: 00801741086090; Package: CA [12 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: 2018-03-29
• 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