ENCOR® ECP017GV

GUDID 10801741086295

ENCOR® Probe Stereotactic/Ultrasound 7GV Upright

SENORX, INC.

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 10801741086295
• NIH Device Record Key: 8dddff75-7ab4-4420-aae1-2f6f66e969cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENCOR®
• Version Model Number: ECP017GV
• Catalog Number: ECP017GV
• 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 Dimensions

• Needle Gauge: 7 Gauge
• Needle Gauge: 7 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741086298 [Primary]
GS1	10801741086295 [Package]; Contains: 00801741086298; Package: CA [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051158

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [ENCOR®]

• 00801741086755: ENCOR® Breast Biopsy System Vacuum System
• 10801741086745: ENCOR® Breast Biopsy System MRI Vacuum Tube Extension
• 00801741086731: ENCOR® Breast Biopsy System Vacuum Package
• 10801741086714: ENCOR® Breast Biopsy System Vacuum Tubing Set
• 10801741086677: ENCOR® Breast Biopsy System Rinse Tubing Set
• 00801741086557: ENCOR® Breast Biopsy System Footswitch For use with EnCor® System
• 00801741086540: ENCOR® Breast Biopsy System MRI Footswitch
• 10801741086523: ENCOR® Breast Biopsy System Needle Guide Insert (Lorad™), 7G
• 10801741086516: ENCOR® Breast Biopsy System Needle Guide Insert (Lorad™), 12G
• 10801741086509: ENCOR® Breast Biopsy System Needle Guide Insert (Lorad™), 10G
• 10801741086486: ENCOR® Breast Biopsy System Needle Guide Insert (GE™/Siemens™/Fischer™/Giotto™), 7G
• 10801741086479: ENCOR® Breast Biopsy System Needle Guide Insert (GE™/Siemens™/Fischer™/Giotto™), 12G
• 10801741086462: ENCOR® Breast Biopsy System Needle Guide Insert (GE™/Siemens™/Fischer™/Giotto™), 10G
• 00801741086458: ENCOR® Breast Biopsy System Fire Forward Accessory
• 00801741086441: ENCOR® Breast Biopsy System Fire Forward Adapter Accessory
• 10801741086424: ENCOR® Breast Biopsy System MRI Needle Guide Insert (Aurora™), 10G
• 10801741086417: ENCOR® Breast Biopsy System Tissue Collection Tray
• 10801741086400: ENCOR® Breast Biopsy System Sample Trap Tray Cover
• 10801741086394: EnCor® Ultrasound Stylet and Coaxial, 7G
• 10801741086387: EnCor® Ultrasound Stylet and Coaxial, 10G
• 10801741086370: EnCor® Ultrasound Stylet and Coaxial, 12G
• 10801741086325: ENCOR® Probe MRI 7G Trocar Tip
• 10801741086318: ENCOR® Probe MRI 10G Blunt Tip
• 10801741086301: ENCOR® Probe MRI 10G Trocar Tip
• 10801741086295: ENCOR® Probe Stereotactic/Ultrasound 7GV Upright
• 10801741086288: ENCOR® Probe Stereotactic/Ultrasound 7G
• 10801741086271: ENCOR® Probe Stereotactic/Ultrasound 12GV Upright
• 10801741086264: ENCOR® Probe Stereotactic/Ultrasound 12G
• 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