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Novalux, Light Source, Medical Grade, Iec Cord, International
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- NOVALUX, LIGHT SOURCE, MEDICAL GRADE, IEC CORD, INTERNATIONAL FDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Model / Reference
- M 797M-725I FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810040251474 FDA UDI
- FDA Product Code
- EPT FDA UDI
- GMDN Term
- General-purpose surgical microscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4700 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose surgical microscope
Novalux, Light Source, Medical Grade, Iec Cord, International by Global Surgical Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Global Surgical Corp.
Sources (1)
- FDA UDI c692dfd1-1522-4c01-a05e-279adcd1b019 32 fields · synced May 30, 2026