Gel Mark UltraCor® Breast Tissue Marker GMUTC005T

GUDID 10801741031905

GEL MARK ULTRACOR Marker, 14 Gauge, Titanium "S"Breast Tissue

SENORX, INC.

Imaging lesion localization marker, implantable

• Primary Device ID: 10801741031905
• NIH Device Record Key: 950d6929-bde3-4900-94e4-a505ab30a4e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gel Mark UltraCor® Breast Tissue Marker
• Version Model Number: GMUTC005T
• Catalog Number: GMUTC005T
• 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: 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

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	00801741031908 [Primary]
GS1	10801741031905 [Package]; Contains: 00801741031908; Package: CA [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040706

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 [Gel Mark UltraCor® Breast Tissue Marker]

• 10801741031905: GEL MARK ULTRACOR Marker, 14 Gauge, Titanium "S"Breast Tissue
• 10801741031899: GEL MARK ULTRACOR Breast Tissue Marker, 14 Gauge, SS "Omega"