| Primary Device ID | 00836462008243 |
| NIH Device Record Key | 6ba892d0-d7b4-4714-9ec6-babe2463de20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SapphireTM |
| Version Model Number | SDS-1 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a clean, dry and secure location |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00836462008243 [Primary] |
| HCG | DEVICE, NEUROVASCULAR EMBOLIZATION |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
[00836462008243]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-02 |
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| 00763000845377 - Axium™ Detachable Coil System | 2025-01-06 COIL QC-2-3-HELIX V14 |
| 00763000845384 - Axium™ Detachable Coil System | 2025-01-06 COIL QC-2-4-HELIX V14 |