FDA UDI
In Commercial Distribution
🇺🇸 United States
Cordis PRECISE PRO Rx Nitinol Stent System
DI: 20705032036396
·
Model: PC0530RXC
·
Cordis US Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cordis PRECISE PRO Rx Nitinol Stent System
- Primary DI
- 20705032036396
- Version / Model
- PC0530RXC
- Catalog Number
- PC0530RXC
- Company Name
- Cordis US Corp.
- Labeler DUNS
- 118274128
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-17
- Public Version
- 10
- Public Version Date
- 2025-09-05
- Public Version Status
- Update
- Public Device Record Key
- ce7e6d55-442e-4095-8c40-6197506f3d3d
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NIM | STENT, CAROTID | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45851 | Bare-metal carotid artery stent | A non-bioabsorbable tubular device dedicated to implantation in a carotid artery to maintain arterial patency and improve luminal diameter in patients with atherosclerotic disease. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] typically in a tubular mesh structure, and is typically delivered to the site of implantation by a dedicated instrument where it self-expands upon release. It is available in a variety of lengths and diameters and may be used in conjunction with an embolic protection device. 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 | 20705032036396 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P030047 | 025 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use if package is damaged
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry