EnCor® ECSTUS0112G

GUDID 10801741086370

EnCor® Ultrasound Stylet and Coaxial, 12G

SENORX, INC.

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 10801741086370
• NIH Device Record Key: 8935564f-081a-4d49-a760-98ad84e1bbdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnCor®
• Version Model Number: ECSTUS0112G
• Catalog Number: ECSTUS0112G
• 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: true
• 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
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com
• Phone: +1(800)321-4254
• Email: medical.services@crbard.com

Device Dimensions

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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741086373 [Primary]
GS1	10801741086370 [Package]; Contains: 00801741086373; Package: CA [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042098

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

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• 10801741086677: ENCOR® Breast Biopsy System Rinse Tubing Set
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• 10801741086417: ENCOR® Breast Biopsy System Tissue Collection Tray
• 10801741086400: ENCOR® Breast Biopsy System Sample Trap Tray Cover
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• 10801741086257: ENCOR® Probe Stereotactic/Ultrasound 10GV Upright
• 10801741086240: ENCOR® Probe Stereotactic/Ultrasound 10G
• 00801741086236: ENCOR® Breast Biopsy System MRI Introducer Set Visiloc™ 7G
• 00801741086229: ENCOR® Breast Biopsy System MRI Introducer Set Visiloc™ 10G
• 10801741086196: ENCOR® Breast Biopsy System 12 Ga Probe Introducer
• 10801741086189: ENCOR® Breast Biopsy System 10 Ga Probe Introducer
• 00801741086083: ENCOR® Breast Biopsy System MRI Driver
• 00801741086076: ENCOR® Breast Biopsy System Driver
• 00801741086052: ENCOR® Breast Biopsy System Control Module