FDA UDI
In Commercial Distribution
🇺🇸 United States
Resolute Onyx™
DI: 00643169557291
·
Model: RONYX50012UX
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Resolute Onyx™
- Primary DI
- 00643169557291
- Version / Model
- RONYX50012UX
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-11
- Public Version
- 7
- Public Version Date
- 2021-06-11
- Public Version Status
- Update
- Public Device Record Key
- efdc5d0e-dc8a-40bf-8146-07a15965f895
Device Description
STENT RONYX50012UX RESOLUTE ONYX 5.00X12
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NIQ | Coronary drug-eluting stent | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56284 | Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated | A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169557291 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160043 | 000 |
| P160043 | 007 |
| P160043 | 011 |
| P160043 | 031 |
| P160043 | 032 |
| P160043 | 037 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Stent Inner Diameter 5.0 MM | ||
| Length | 12.0 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius