Axium Detachable Coil System

GUDID 00847536044609

COIL PC-4-6-3D V05

Micro Therapeutics, Inc.

Neurovascular embolization coil
Primary Device ID00847536044609
NIH Device Record Keyb1148d95-6912-4690-b56c-7e9745e32c77
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxium Detachable Coil System
Version Model NumberPC-4-6-3D
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *store in a cool dry place
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100847536044609 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-13
Device Publish Date2022-06-04

On-Brand Devices [Axium Detachable Coil System]

00847536038035COIL QC-25-50-3D V05
00847536038028COIL QC-22-50-3D V05
00847536038011COIL QC-20-50-3D V05
00847536038004COIL QC-18-40-3D V05
00847536037991COIL QC-16-40-3D V05
00847536037984COIL QC-14-40-3D V05
00847536037977COIL QC-14-30-3D V05
00847536037960COIL QC-12-40-3D V05
00847536037953COIL QC-12-30-3D V05
00847536037946COIL QC-10-30-3D V05
00847536037939COIL QC-10-20-3D V05
00847536037922COIL QC-9-30-3D V05
00847536037915COIL QC-9-20-3D V05
00847536037908COIL QC-8-30-3D V05
00847536037892COIL QC-8-20-3D V05
00847536037885COIL QC-8-15-3D V05
00847536037878COIL QC-7-30-3D V05
00847536037861COIL QC-7-20-3D V05
00847536037854COIL QC-7-15-3D V05
00847536037847COIL QC-6-20-3D V05
00847536037830COIL QC-6-15-3D V05
00847536037823COIL QC-6-10-3D V05
00847536037816COIL QC-5-15-3D V05
00847536037809COIL QC-5-10-3D V05
00847536037793COIL QC-5-8-3D V05
00847536037779COIL QC-4-10-3D V05
00847536037762COIL QC-4-8-3D V05
00847536037755COIL QC-4-6-3D V05
00847536037748COIL QC-3.5-15-3D V05
00847536037731COIL QC-3.5-12-3D V05
00847536037724COIL QC-3.5-6-3D V05
00847536037717COIL QC-3-10-3D V05
00847536037700COIL QC-3-8-3D V05
00847536037694COIL QC-3-6-3D V05
00847536037687COIL QC-3-4-3D V05
00847536037670COIL QC-2.5-8-3D V05
00847536037663COIL QC-2.5-6-3D V05
00847536037656COIL QC-2.5-4-3D V05
00847536037649COIL QC-2.5-2-3D V05
00847536037632COIL QC-2-6-3D V05
00847536037625COIL QC-2-4-3D V05
00847536037618COIL QC-2-2-3D V05
00847536037601COIL QC-20-50-HELIX V05
00847536037595COIL QC-20-40-HELIX V05
00847536037588COIL QC-18-40-HELIX V05
00847536037571COIL QC-16-40-HELIX V05
00847536037564COIL QC-16-30-HELIX V05
00847536037557COIL QC-14-40-HELIX V05
00847536037540COIL QC-14-30-HELIX V05
00847536037533COIL QC-12-40-HELIX V05
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