Gel Mark Ultra™ Breast Tissue Marker GMUEC10GSS

GUDID 10801741031851

GEL MARK ULTRA™ Breast Tissue Marker, 10 Ga EnCor, SS "Omega"

SENORX, INC.

Imaging lesion localization marker, implantable

• Primary Device ID: 10801741031851
• NIH Device Record Key: 5d0dfaf6-8c1e-402e-a753-2b656f2f7d90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gel Mark Ultra™ Breast Tissue Marker
• Version Model Number: GMUEC10GSS
• Catalog Number: GMUEC10GSS
• 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	00801741031854 [Primary]
GS1	10801741031851 [Package]; Contains: 00801741031854; Package: CA [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011402

FDA Product Code

• FZP: CLIP, 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 Ultra™ Breast Tissue Marker]

• 10801741031882: GEL MARK ULTRA™ Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"
• 10801741031868: GEL MARK ULTRA™ Breast Tissue Marker, 7 Ga EnCor, SS "Omega"
• 10801741031851: GEL MARK ULTRA™ Breast Tissue Marker, 10 Ga EnCor, SS "Omega"
• 10801741031844: GEL MARK ULTRA™ Breast Tissue Marker, 11 Ga Mammotome, Titanium "S"