Resolute Onyx™
GUDID 00643169557086
STENT RONYX35018UX RESOLUTE ONYX 3.50X18
MEDTRONIC, INC.
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated| Primary Device ID | 00643169557086 |
| NIH Device Record Key | b0bb650c-bf98-497e-a6ff-e5ec0e022d8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Resolute Onyx™ |
| Version Model Number | RONYX35018UX |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, 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 | true |
| 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
Device Dimensions
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| Length | 18 Millimeter |
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| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169557086 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P160043
FDA Product Code
| NIQ | Coronary drug-eluting stent |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-11 |
On-Brand Devices [Resolute Onyx™]
| 00643169602748 | STENT RONYX40038W RESOLUTE ONYX 4.00X38 |
| 00643169602731 | STENT RONYX40034W RESOLUTE ONYX 4.00X34 |
| 00643169602724 | STENT RONYX40030W RESOLUTE ONYX 4.00X30 |
| 00643169602717 | STENT RONYX40026W RESOLUTE ONYX 4.00X26 |
| 00643169602700 | STENT RONYX40022W RESOLUTE ONYX 4.00X22 |
| 00643169602694 | STENT RONYX40018W RESOLUTE ONYX 4.00X18 |
| 00643169602687 | STENT RONYX40015W RESOLUTE ONYX 4.00X15 |
| 00643169602670 | STENT RONYX40012W RESOLUTE ONYX 4.00X12 |
| 00643169602663 | STENT RONYX40008W RESOLUTE ONYX 4.00X08 |
| 00643169602656 | STENT RONYX35038W RESOLUTE ONYX 3.50X38 |
| 00643169602649 | STENT RONYX35034W RESOLUTE ONYX 3.50X34 |
| 00643169602632 | STENT RONYX35030W RESOLUTE ONYX 3.50X30 |
| 00643169602625 | STENT RONYX35026W RESOLUTE ONYX 3.50X26 |
| 00643169602618 | STENT RONYX35022W RESOLUTE ONYX 3.50X22 |
| 00643169602601 | STENT RONYX35018W RESOLUTE ONYX 3.50X18 |
| 00643169602595 | STENT RONYX35015W RESOLUTE ONYX 3.50X15 |
| 00643169602588 | STENT RONYX35012W RESOLUTE ONYX 3.50X12 |
| 00643169602571 | STENT RONYX35008W RESOLUTE ONYX 3.50X08 |
| 00643169602564 | STENT RONYX30038W RESOLUTE ONYX 3.00X38 |
| 00643169602557 | STENT RONYX30034W RESOLUTE ONYX 3.00X34 |
| 00643169602540 | STENT RONYX30030W RESOLUTE ONYX 3.00X30 |
| 00643169602533 | STENT RONYX30026W RESOLUTE ONYX 3.00X26 |
| 00643169602526 | STENT RONYX30022W RESOLUTE ONYX 3.00X22 |
| 00643169602519 | STENT RONYX30018W RESOLUTE ONYX 3.00X18 |
| 00643169602502 | STENT RONYX30015W RESOLUTE ONYX 3.00X15 |
| 00643169602496 | STENT RONYX30012W RESOLUTE ONYX 3.00X12 |
| 00643169602489 | STENT RONYX30008W RESOLUTE ONYX 3.00X08 |
| 00643169602472 | STENT RONYX27538W RESOLUTE ONYX 2.75X38 |
| 00643169602465 | STENT RONYX27534W RESOLUTE ONYX 2.75X34 |
| 00643169602458 | STENT RONYX27530W RESOLUTE ONYX 2.75X30 |
| 00643169602441 | STENT RONYX27526W RESOLUTE ONYX 2.75X26 |
| 00643169602434 | STENT RONYX27522W RESOLUTE ONYX 2.75X22 |
| 00643169602427 | STENT RONYX27518W RESOLUTE ONYX 2.75X18 |
| 00643169602410 | STENT RONYX27515W RESOLUTE ONYX 2.75X15 |
| 00643169602403 | STENT RONYX27512W RESOLUTE ONYX 2.75X12 |
| 00643169602397 | STENT RONYX27508W RESOLUTE ONYX 2.75X08 |
| 00643169602380 | STENT RONYX25038W RESOLUTE ONYX 2.50X38 |
| 00643169602373 | STENT RONYX25034W RESOLUTE ONYX 2.50X34 |
| 00643169602366 | STENT RONYX25030W RESOLUTE ONYX 2.50X30 |
| 00643169602359 | STENT RONYX25026W RESOLUTE ONYX 2.50X26 |
| 00643169602342 | STENT RONYX25022W RESOLUTE ONYX 2.50X22 |
| 00643169602335 | STENT RONYX25018W RESOLUTE ONYX 2.50X18 |
| 00643169602328 | STENT RONYX25015W RESOLUTE ONYX 2.50X15 |
| 00643169602311 | STENT RONYX25012W RESOLUTE ONYX 2.50X12 |
| 00643169602304 | STENT RONYX25008W RESOLUTE ONYX 2.50X08 |
| 00643169602298 | STENT RONYX22538W RESOLUTE ONYX 2.25X38 |
| 00643169602281 | STENT RONYX22534W RESOLUTE ONYX 2.25X34 |
| 00643169602274 | STENT RONYX22530W RESOLUTE ONYX 2.25X30 |
| 00643169602267 | STENT RONYX22526W RESOLUTE ONYX 2.25X26 |
| 00643169602250 | STENT RONYX22522W RESOLUTE ONYX 2.25X22 |
Trademark Results [Resolute Onyx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESOLUTE ONYX 86098251 5228405 Live/Registered |
Medtronic Vascular, Inc. 2013-10-22 |
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