SenoMark® Breast Tissue Marker SMTEC10G

GUDID 10801741031974

SENOMARK® Breast Tissue Marker, 10 Ga EnCor, Titanium "O"

SENORX, INC.

Imaging lesion localization marker, implantable

• Primary Device ID: 10801741031974
• NIH Device Record Key: 7ac24b26-c8e1-42e3-9361-d144099a90c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SenoMark® Breast Tissue Marker
• Version Model Number: SMTEC10G
• Catalog Number: SMTEC10G
• 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

• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 Gauge
• Needle Gauge: 10 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	00801741031977 [Primary]
GS1	10801741031974 [Package]; Contains: 00801741031977; Package: CA [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050090

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: 2015-10-01

On-Brand Devices [SenoMark® Breast Tissue Marker]

• 10801741031998: SENOMARK® Breast Tissue Marker, 9 Ga ATEC, Titanium "O"
• 10801741031981: SENOMARK® Breast Tissue Marker, 11 Ga Mammotome, Titanium "O"
• 10801741031974: SENOMARK® Breast Tissue Marker, 10 Ga EnCor, Titanium "O"
• 10801741031967: SENOMARK® Breast Tissue Marker, 9 Ga Eviva, Titanium "X"
• 10801741031950: SENOMARK® Breast Tissue Marker, Rigid, 9 Ga ATEC, Titanium "X"
• 10801741031943: SENOMARK® Breast Tissue Marker, Rigid, 12 Ga ATEC, Titanium "S"
• 10801741031936: SENOMARK® Breast Tissue Marker, 7 Ga EnCor, SS "M"
• 10801741031929: SENOMARK® Breast Tissue Marker, 12 Ga EnCor, SS "Omega"
• 10801741031912: SENOMARK® Breast Tissue Marker, 10 Ga EnCor, SS "M"