FDA UDI
In Commercial Distribution
🇺🇸 United States
NIRxcell™ CoCr Coronary Stent on RX System
DI: 07290107012980
·
Model: NXL40015US
·
MEDINOL LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NIRxcell™ CoCr Coronary Stent on RX System
- Primary DI
- 07290107012980
- Version / Model
- NXL40015US
- Company Name
- MEDINOL LTD.
- Labeler DUNS
- 600593800
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-09
- Public Version
- 4
- Public Version Date
- 2019-10-07
- Public Version Status
- Update
- Public Device Record Key
- 1d981dcf-4474-4c75-b443-d2bc1fe0e439
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- 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 |
|---|---|---|---|---|
| MAF | Stent, Coronary | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53616 | Bare-metal coronary artery stent | A non-bioabsorbable tubular device [bare metal stent (BMS)] intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic heart disease. It is typically made of high-grade stainless steel or cobalt-chrome (Co-Cr), may be linear or have a bifurcation design (e.g., shaped as a Y in a tube form), and may be balloon-expanded or self-expandable. Dedicated disposable implantation devices (e.g., balloon catheter, delivery instrument) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290107012980 | GS1 |
Customer Contacts
- Phone
- 1-800-477-5801
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P110004 | 018 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 15 | Millimeter | |
| Outer Diameter | 4.0 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dark, dry place