FDA UDI
In Commercial Distribution
🇺🇸 United States
EluNIR-PERL Ridaforolimus Eluting Coronary Stent System
DI: 07290107015202
·
Model: ELM250R08US
·
MEDINOL LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EluNIR-PERL Ridaforolimus Eluting Coronary Stent System
- Primary DI
- 07290107015202
- Version / Model
- ELM250R08US
- Company Name
- MEDINOL LTD.
- Labeler DUNS
- 600593800
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-10
- Public Version
- 1
- Public Version Date
- 2023-12-18
- Public Version Status
- New
- Public Device Record Key
- f4ac95fa-e64e-4939-9a80-a5208412a676
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
- Yes
- 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
- Yes
- 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 | 07290107015202 | GS1 |
Customer Contacts
- Phone
- (720) 386 5585
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P170008 | 037 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Millimeter | |
| Lumen/Inner Diameter | 2.5 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not remove from carton until ready for use. Store in a dry place, away from direct sunlight, at up to 25°C (77°F), with transient excursions allowed up to 40°C (104°F).