Identity
- Trade Name
- LithoVue FDA UDI
- Generic Name
- Flexible video ureteroscope, reusable FDA UDI
- Device Name
- System Workstation FDA UDI
- Model / Reference
- M006791100R0 FDA UDI
- Description
- System Workstation FDA UDI
Identifiers
- Catalog Number
- M006791100R0 FDA UDI
- Primary DI / UDI-DI
- 08714729880912 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Flexible video ureteroscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video ureteroscope, reusable
LithoVue by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- F88 — Sg Endoscopy Pte, Ltd. · Class II
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
- Boston Scientific
Sources (1)
- FDA UDI 66902938-5039-4fe4-ad3c-226166cf2752 34 fields · synced May 31, 2026