Identity
- Trade Name
- TightRail Rotating Dilator Sheath EUDAMEDFDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Device Name
- TightRail Rotating Dilator Sheath EUDAMED
- Model / Reference
- 545-513 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 545-513 FDA UDI
- Primary DI / UDI-DI
- 00813132020897 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132020897 EUDAMED
- FDA Product Code
- DRE FDA UDI
- EMDN Code
- C9002 VASCULAR AND FASCIAL DILATORS EUDAMED
- GMDN Term
- Vascular dilator, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1310 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.171 Inch FDA UDIOuter Diameter — 0.260 Inch FDA UDILength — 47.5 Centimeter FDA UDI
Category: Fascial tissue dilator, single-use
TightRail Rotating Dilator Sheath by Spectranetics Corporation — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Fascial tissue dilator, single-use.
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- Cook — COOK INCORPORATED · Class II
- Byrd — COOK INCORPORATED · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813132020897 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (2)
- EUDAMED d9769893-f881-46af-a24e-9e3e466cf1b5 61 fields · synced Jul 9, 2026
- FDA UDI a1263920-a798-4033-87d0-51b24a70aae6 36 fields · synced May 30, 2026