AXIUM
GUDID 00836462010673
PC-4-8-HELIX AXIUM 4MM X 8CM COIL
Micro Therapeutics, Inc.
Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil| Primary Device ID | 00836462010673 |
| NIH Device Record Key | 63935c21-3365-4d5b-ae0e-de7bda067c74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AXIUM |
| Version Model Number | PC-4-8-HELIX |
| Company DUNS | 826110710 |
| Company Name | Micro Therapeutics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
| Length | 8 Centimeter |
| Outer Diameter | 4 Millimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid extreme temperatures;Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00836462010673 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081465
FDA Product Code
| KRD | Device, Vascular, for Promoting Embolization |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-07-26 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [AXIUM]
| 00847536002012 | Detachable Coil System |
| 00847536002005 | Detachable Coil System |
| 00847536001992 | Detachable Coil System |
| 00847536001985 | Detachable Coil System |
| 00847536001978 | Detachable Coil System |
| 00847536001961 | Detachable Coil System |
| 00847536001954 | Detachable Coil System |
| 00847536001947 | Detachable Coil System |
| 00847536001930 | Detachable Coil System |
| 00847536001923 | Detachable Coil System |
| 00847536001916 | Detachable Coil System |
| 00847536001909 | Detachable Coil System |
| 00847536001893 | Detachable Coil System |
| 00847536001886 | Detachable Coil System |
| 00847536001879 | Detachable Coil System |
| 00836462010536 | QC-22-50-3D BARE AXIUM 3D COIL |
| 00836462010888 | PC-8-20-3D AXIUM 3D 8MM X 20CM COIL |
| 00836462010871 | PC-7-30-3D AXIUM 3D 7MM X 30CM COIL |
| 00836462010864 | PC-7-20-3D AXIUM 3D 7MM X 20CM COIL |
| 00836462010857 | PC-6-20-3D AXIUM 3D 6MM X 20CM COIL |
| 00836462010765 | PC-10-30-HELIX AXIUM 10MMX30CM COIL |
| 00836462010758 | PC-9-30-HELIX AXIUM 9MM X 30CM |
| 00836462010741 | PC-8-30-HELIX AXIUM 8MM X 30CM |
| 00836462010734 | PC-7-30-HELIX AXIUM 7MM X 30CM |
| 00836462010727 | PC-6-20-HELIX AXIUM 6MM X 20CM |
| 00836462010697 | PC-4-12-HELIX AXIUM 4MM X 12CM |
| 00836462010680 | PC-4-10-HELIX AXIUM 4MM X 10CM |
| 00836462010673 | PC-4-8-HELIX AXIUM 4MM X 8CM COIL |
| 00836462012615 | PC-6-10-3D AXIUM 3D 6MM X 10CM |
| 00836462012608 | PC-5-8-3D AXIUM 3D 5MM X 8CM |
| 00836462012592 | PC-4-10-3D AXIUM 3D 4MM X 10CM |
| 00836462012585 | PC-4-6-3D AXIUM 3D 4MM X 6CM |
| 00836462012578 | QC-6-10-3D BARE AXIUM 3D COIL |
| 00836462012561 | QC-5-8-3D BARE AXIUM 3D COIL |
| 00836462012554 | QC-4-10-3D BARE AXIUM 3D COIL |
| 00836462012547 | QC-4-6-3D BARE AXIUM 3D COIL |
| 00836462012530 | PC-10-20-HELIX AXIUM HELIX 10MM X 20CM |
| 00836462012523 | PC-9-20-HELIX AXIUM HELIX 9MM X 20CM |
| 00836462012516 | PC-8-20-HELIX AXIUM HELIX 8MM X 20CM |
| 00836462012479 | QC-14-40-HELIX BARE AXIUM HELIX COIL |
| 00836462012462 | QC-12-40-HELIX BARE AXIUM HELIX COIL |
| 00836462012455 | QC-10-20-HELIX BARE AXIUM HELIX COIL |
| 00836462012448 | QC-9-20-HELIX BARE AXIUM HELIX COIL |
| 00836462012431 | QC-8-20-HELIX BARE AXIUM HELIX COIL |
| 00836462012424 | QC-7-20-HELIX BARE AXIUM HELIX COIL |
| 00836462012417 | QC-14-30-3D BARE AXIUM 3D COIL |
| 00836462012400 | QC-12-30-3D BARE AXIUM 3D COIL |
| 00836462012394 | QC-8-15-3D BARE AXIUM 3D COIL |
| 00836462012387 | QC-7-15-3D BARE AXIUM 3D COIL |
| 00836462012196 | PC-18-40-3D AXIUM 3D 18MM X 40CM |
Trademark Results [AXIUM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AXIUM 97769154 not registered Live/Pending |
Axium Solutions ULC 2023-01-26 |
 AXIUM 97763019 not registered Live/Pending |
Year33 Inc. 2023-01-20 |
 AXIUM 90596375 not registered Live/Pending |
Vadovations, Inc. 2021-03-23 |
 AXIUM 88381237 not registered Live/Pending |
KINETICO INCORPORATED 2019-04-11 |
 AXIUM 87338441 not registered Dead/Abandoned |
L18 Holdings, Inc. 2017-02-16 |
 AXIUM 85872397 not registered Dead/Abandoned |
Automatic Equipment Manufacturing Company 2013-03-11 |
 AXIUM 85463170 4564567 Live/Registered |
Spinal Modulation, Inc. 2011-11-03 |
 AXIUM 85194906 3997317 Dead/Cancelled |
Master Brands HK Limited 2010-12-10 |
 AXIUM 85194877 3997315 Dead/Cancelled |
Master Brands HK Limited 2010-12-10 |
 AXIUM 79243756 not registered Live/Pending |
INGENICO GROUP 2018-07-09 |
 AXIUM 78761181 not registered Dead/Abandoned |
Axium Management, Inc. 2005-11-27 |
 AXIUM 78748165 3540355 Live/Registered |
Axium Consulting LLC 2005-11-07 |
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