Identity
- Trade Name
- SightRail™ FDA UDI
- Generic Name
- Vascular dilator, single-use FDA UDI
- Device Name
- SightRail™ Manual Dilator Sheath FDA UDI
- Model / Reference
- 550-008 FDA UDI
- Description
- SightRail™ Manual Dilator Sheath FDA UDI
Identifiers
- Catalog Number
- 550-008 FDA UDI
- Primary DI / UDI-DI
- M2045500080 FDA UDI
- 510(k) Number
- K133631 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 — 0.107 Inch FDA UDI
SightRail™ 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spectranetics Corporation
Sources (1)
- FDA UDI e4e5207d-5ae5-4071-9b95-a2e9565b6137 39 fields · synced Jun 8, 2026