NXTTM

GUDID 00836462017184

N-4-8-T10-SO NXT COIL HELIX SOFT

Micro Therapeutics, Inc.

Neurovascular embolization coil
Primary Device ID00836462017184
NIH Device Record Key8c21ef27-d056-493a-88d4-c9cc9be29301
Commercial Distribution StatusIn Commercial Distribution
Brand NameNXTTM
Version Model NumberN-4-8-T10-SO
Company DUNS826110710
Company NameMicro Therapeutics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry cool place

Device Identifiers

Device Issuing AgencyDevice ID
GS100836462017184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


[00836462017184]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-02

Devices Manufactured by Micro Therapeutics, Inc.

00763000845315 - Axium™ Detachable Coil System2025-01-06 COIL QC-1.5-1-HELIX V14
00763000845322 - Axium™ Detachable Coil System2025-01-06 COIL QC-1.5-2-HELIX V14
00763000845339 - Axium™ Detachable Coil System2025-01-06 COIL QC-1.5-3-HELIX V14
00763000845346 - Axium™ Detachable Coil System2025-01-06 COIL QC-1.5-4-HELIX V14
00763000845353 - Axium™ Detachable Coil System2025-01-06 COIL QC-2-1-HELIX V14
00763000845360 - Axium™ Detachable Coil System2025-01-06 COIL QC-2-2-HELIX V14
00763000845377 - Axium™ Detachable Coil System2025-01-06 COIL QC-2-3-HELIX V14
00763000845384 - Axium™ Detachable Coil System2025-01-06 COIL QC-2-4-HELIX V14

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