StarchMark® UltraCor™ Breast Tissue Marker STMK14GSS

GUDID 10801741032193

STARCHMARK® ULTRACOR™ Breast Tissue Marker, 14 Ga, SS “V”

SENORX, INC.

Imaging lesion localization marker, implantable

• Primary Device ID: 10801741032193
• NIH Device Record Key: 5955ae5d-f031-4099-8781-73c8fe3934b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StarchMark® UltraCor™ Breast Tissue Marker
• Version Model Number: STMK14GSS
• Catalog Number: STMK14GSS
• 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
• 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

• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 14 Gauge

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741032196 [Primary]
GS1	10801741032193 [Package]; Contains: 00801741032196; Package: CA [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131654

FDA Product Code

• NEU: MARKER, RADIOGRAPHIC, IMPLANTABLE

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: 2015-10-02

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• 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