Identity
- Trade Name
- TightRail™ FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Device Name
- TightRail™ Rotating Dilator Sheath FDA UDI
- Model / Reference
- 545-513 FDA UDI
- Description
- TightRail™ Rotating Dilator Sheath FDA UDI
Identifiers
- Catalog Number
- 545-513 FDA UDI
- Primary DI / UDI-DI
- M2045455130 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Vascular dilator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.171 Inch FDA UDI
TightRail™ by Spectranetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
Sources (1)
- FDA UDI 64aa9bf5-2eea-4e16-91c1-8b55e6b24929 38 fields · synced Jun 1, 2026