| Primary Device ID | 00847536004580 |
| NIH Device Record Key | 1b37ff8a-a132-4f97-ad01-4561f818bf12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | X-celeratorTM |
| Version Model Number | 103-0602-300 |
| Company DUNS | 826110710 |
| Company Name | Micro Therapeutics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 |
| 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 | |
| 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 |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00847536004580 [Primary] |
| DQX | WIRE, GUIDE, CATHETER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
[00847536004580]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-07-16 |
| 00847536004658 | 103-0602-350 XCELERATOR14 GWIRE 300CM |
| 00847536004641 | 103-0602-350 XCELERATOR14 GWIRE 300CM |
| 00847536004634 | 103-0602-350 XCELERATOR14 GWIRE |
| 00847536004627 | 103-0602-350 XCELERATOR14 GWIRE |
| 00847536004610 | 103-0602-300 XCELERATOR14 GWIRE 300CM |
| 00847536004603 | 103-0602-300 XCELERATOR14 GWIRE 300CM |
| 00847536004597 | 103-0602-300 XCELERATOR14 GWIRE |
| 00847536004580 | 103-0602-300 XCELERATOR14 GWIRE |
| 00847536004481 | 103-0601-350 XCELERATOR10 GWIRE 300CM |
| 00847536004474 | 103-0601-350 XCELERATOR10 GWIRE 300CM |
| 00847536004467 | 103-0601-350 XCELERATOR10 GWIRE ATH |
| 00847536004450 | 103-0601-350 XCELERATOR10 GWIRE ATH |
| 00847536004443 | 103-0601-300 XCELERATOR10 GWIRE 300CM |
| 00847536004436 | 103-0601-300 XCELERATOR10 GWIRE 300CM |
| 00847536004429 | 103-0601-300 XCELERATOR10 GWIRE ATH |
| 00847536004412 | 103-0601-300 XCELERATOR10 GWIRE ATH |
| 00847536004405 | 103-0601-300 X-CELERATOR 10 300CM |