SenoMark® UltraCor® Breast Tissue Marker SMUC13V

GUDID 10801741032360

SenoMark® UltraCor® 14G x 13CM Venus

Bard Peripheral Vascular, Inc.

Imaging lesion localization marker, implantable

• Primary Device ID: 10801741032360
• NIH Device Record Key: 12a87aca-e78a-4263-9fb5-324461eb3539
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SenoMark® UltraCor® Breast Tissue Marker
• Version Model Number: SMUC13V
• Catalog Number: SMUC13V
• Company DUNS: 135057938
• Company Name: Bard Peripheral Vascular, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741032363 [Primary]
GS1	10801741032360 [Package]; Contains: 00801741032363; Package: CA [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123911

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: 2015-09-25

On-Brand Devices [SenoMark® UltraCor® Breast Tissue Marker]

• 10801741032407: SenoMark® UltraCor® 14G x 10CM Venus
• 10801741032391: SenoMark® UltraCor® 14G x 10CM Heart
• 10801741032384: SenoMark® UltraCor® 14G x 10CM Coil
• 10801741032377: SenoMark® UltraCor® 14G x 10CM Ribbon
• 10801741032360: SenoMark® UltraCor® 14G x 13CM Venus
• 10801741032353: SenoMark® UltraCor® 14G x 13CM Heart
• 10801741032346: SenoMark® UltraCor® 14G x 13CM Coil
• 10801741032339: SenoMark® UltraCor® 14G x 13CM Ribbon