ENCOR ULTRA® SCTUB4000

GUDID 10801741086721

ENCOR ULTRA® Breast Biopsy System Vacuum Tubing

SENORX, INC.

Mammographic stereotactic biopsy system

• Primary Device ID: 10801741086721
• NIH Device Record Key: fb4e88f1-045b-4351-aa6a-13037e216366
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENCOR ULTRA®
• Version Model Number: SCTUB4000
• Catalog Number: SCTUB4000
• 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: 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	00801741086724 [Primary]
GS1	10801741086721 [Package]; Contains: 00801741086724; Package: CA [10 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• 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