Identity
- Trade Name
- Turbo Elite™ FDA UDI
- Generic Name
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
- Device Name
- Turbo-Elite™ Laser Atherectomy Catheter FDA UDI
- Model / Reference
- 425-135-01 FDA UDI
- Description
- Turbo-Elite™ Laser Atherectomy Catheter FDA UDI
Identifiers
- Catalog Number
- 425-135-01 FDA UDI
- Primary DI / UDI-DI
- M204425135010 FDA UDI
- FDA Product Code
- MCW FDA UDI
- GMDN Term
- Atherectomy laser system beam guide-catheter, peripheral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 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
No
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
- Outer Diameter — 2.6 Millimeter FDA UDI
Turbo Elite™ 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 a5bad744-7b42-4b8e-a780-aa39b437b401 38 fields · synced Jun 6, 2026