TightRail Mini Rotating Dilator Sheath
EUDAMEDFDA UDIClass III (EU MDR)
Identity
- Trade Name
- TightRail Mini Rotating Dilator Sheath EUDAMEDFDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Device Name
- TightRail Mini Rotating Dilator Sheath EUDAMED
- Model / Reference
- 540-011 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 540-011 FDA UDI
- Primary DI / UDI-DI
- 00813132021627 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132021627 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.145 Inch FDA UDIOuter Diameter — 0.234 Inch FDA UDILength — 15.5 Centimeter FDA UDI
Category: Fascial tissue dilator, single-use
TightRail Mini 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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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813132021627 | 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 04eba4fd-7254-4bd5-96c0-da4b628076dd 61 fields · synced Aug 1, 2026
- FDA UDI a05cfe4f-8af9-4375-980f-d7a30f4796d0 36 fields · synced May 30, 2026