Axium
GUDID 00836462010239
QC-16-30-HELIX BARE AXIUM HELIX COIL
Micro Therapeutics, Inc.
Neurovascular embolization coil| Primary Device ID | 00836462010239 |
| NIH Device Record Key | 9c8fc76f-2ef6-4941-a86d-1fb83ab0e7dc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axium |
| Version Model Number | QC-16-30-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
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
| Outer Diameter | 16 Millimeter |
| Length | 30 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry;Avoid extreme temperatures;AVOID DIRECT SUNLIGHT |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00836462010239 [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 | 4 |
| Public Version Date | 2019-07-03 |
| 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 98781884 not registered Live/Pending |
AXIUM PACKAGING LLC 2024-10-02 |
 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 |
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