MO.MA ULTRA

GUDID 08033477090719

CATH MUS0130069X6 CPD ULTRA US 9F UL950

MEDTRONIC, INC.

Carotid artery embolic protection system Carotid artery embolic protection system Carotid artery embolic protection system Carotid artery embolic protection system Carotid artery embolic protection system Carotid artery embolic protection system Carotid artery embolic protection system Carotid artery embolic protection system

• Primary Device ID: 08033477090719
• NIH Device Record Key: 10a6da1a-20e5-4955-808d-cd2d0f07a8ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MO.MA ULTRA
• Version Model Number: MUS0130069X6
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).
• Special Storage Condition, Specify: Between 0 and 0 *Store at controlled room temperature, in a dry place. Keep away from sunlight. Do not expose to organic solvents (e.g., acetone, alcohol).

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033477090719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092177

FDA Product Code

• NTE: Temporary Carotid Catheter for Embolic Capture

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-09
• Device Publish Date: 2020-10-30

On-Brand Devices [MO.MA ULTRA]

• 08033477071909: CATH MUS0130069X6 CPD ULTRA US 9F UL950
• 08033477050140: Cath MUS0130069X6 CPD Ultra US 9F UL950
• 08033477090719: CATH MUS0130069X6 CPD ULTRA US 9F UL950