Identity
- Trade Name
- DUROSCOPE FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- Fiber optic Light guide FDA UDI
- Model / Reference
- LC-0507-B FDA UDI
- Description
- Fiber optic Light guide FDA UDI
Identifiers
- Catalog Number
- LC-0507-B FDA UDI
- Primary DI / UDI-DI
- 00863333000303 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Duroscope by FMD Co., Ltd. — 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
- FMD Co., Ltd.
Sources (1)
- FDA UDI c0db0350-32eb-4443-bcf9-da08e47340bc 35 fields · synced May 30, 2026