StarchMark® UltraCor™ Breast Tissue Marker STMK14GSS

GUDID 10801741032193

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

SENORX, INC.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image 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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