Identity
- Trade Name
- RAILWAY Sheathless Access System EUDAMEDRAILWAY FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Catheter Sheath Introducer - RAILWAY™ Sheathless Access System - Bare Mini Guidewire EUDAMEDRAILWAY ACCESS KIT, 5F, ADT, SS WIRE FDA UDI
- Model / Reference
- RW5ADTB EUDAMEDFDA UDI
- Description
- RAILWAY ACCESS KIT, 5F, ADT, SS WIRE FDA UDI
Identifiers
- Catalog Number
- RW5ADTB FDA UDI
- Primary DI / UDI-DI
- 10705032076845 EUDAMEDFDA UDI
- Basic UDI-DI
- 07050320000000000000054CQ EUDAMED
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
Yes
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Interventional radiology percutaneous-access kit, single-use
RAILWAY Sheathless Access System by Cordis US Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Interventional radiology percutaneous-access kit, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 07050320000000000000054CQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cordis US Corp.
- EUDAMED SRN
- US-MF-000020031
- Authorised Representative
- Cordis Cashel IE-AR-000017793
Sources (2)
- EUDAMED f7ca910f-cd59-45da-b63f-020c1296783b 61 fields · synced Jul 9, 2026
- FDA UDI 8e7d0736-534a-44ed-b300-5fa23c712ed1 35 fields · synced May 25, 2026