Instant Detacher

GUDID 20763000290706

Detacher ID-1-5 V02

Micro Therapeutics, Inc.

Vascular implant detacher, electronic, single-use
Primary Device ID20763000290706
NIH Device Record Keyed9517a3-fc96-4aa2-9220-367c43412c2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstant Detacher
Version Model NumberID-1-5
Company DUNS826110710
Company NameMicro Therapeutics, 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 Latextrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch
Depth6.6 Inch
Length9.9 Inch
Height4 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place, away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000290702 [Primary]
GS120763000290706 [Package]
Contains: 00763000290702
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, for Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-05-03
Device Publish Date2023-01-30

Devices Manufactured by Micro Therapeutics, Inc.

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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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