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Cordis PRECISE RX Nitinol Stent System
FDA UDIClass III (US FDA UDI)
by Cordis Corp.
Identity
- Trade Name
- Cordis PRECISE RX Nitinol Stent System FDA UDI
- Generic Name
- Bare-metal carotid artery stent FDA UDI
- Model / Reference
- P08030RXC FDA UDI
Identifiers
- Catalog Number
- P08030RXC FDA UDI
- Primary DI / UDI-DI
- 20705032035429 FDA UDI
- PMA Number
- P030047 FDA UDI
- FDA Product Code
- NIM FDA UDI
- GMDN Term
- Bare-metal carotid artery stent FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Cordis PRECISE RX Nitinol Stent System by Cordis Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P030047 also covers:
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
- Cordis PRECISE Nitinol Stent System — Cordis Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Cordis Corp.
Sources (1)
- FDA UDI 41d82b9f-f248-40da-adac-935ac0905e00 35 fields · synced Jun 8, 2026