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 ID08033477090719
NIH Device Record Key10a6da1a-20e5-4955-808d-cd2d0f07a8ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameMO.MA ULTRA
Version Model NumberMUS0130069X6
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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, SpecifyBetween 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 AgencyDevice ID
GS108033477090719 [Primary]
GS108033477090719 [Primary]
GS108033477090719 [Primary]
GS108033477090719 [Primary]
GS108033477090719 [Primary]
GS108033477090719 [Primary]
GS108033477090719 [Primary]
GS108033477090719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NTETemporary Carotid Catheter for Embolic Capture
NTETemporary Carotid Catheter for Embolic Capture
NTETemporary Carotid Catheter for Embolic Capture
NTETemporary Carotid Catheter for Embolic Capture
NTETemporary Carotid Catheter for Embolic Capture
NTETemporary Carotid Catheter for Embolic Capture
NTETemporary Carotid Catheter for Embolic Capture
NTETemporary Carotid Catheter for Embolic Capture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [MO.MA ULTRA]

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

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