Identity
- Trade Name
- Endophotocoagulation Delivery Unit FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- The delivery unit is used for endophotocoagulation. The photocoagulation system can be easily comprised by connecting the optional sterilized endophoto probe or optional sterilized coaxial illumination probe to the Green Laser Photocoagulator GYC-1000 and GYC-500, and attaching the protective filter to the main laser device as well as the surgical microscope. This photocoagulation system enables laser endophotocoagulation while observing the affected area through the surgical microscope. FDA UDI
- Model / Reference
- 11143-0000(9G4P) FDA UDI
- Description
- The delivery unit is used for endophotocoagulation. The photocoagulation system can be easily comprised by connecting the optional sterilized endophoto probe or optional sterilized coaxial illumination probe to the Green Laser Photocoagulator GYC-1000 and GYC-500, and attaching the protective filter to the main laser device as well as the surgical microscope. This photocoagulation system enables laser endophotocoagulation while observing the affected area through the surgical microscope. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987669100974 FDA UDI
- FDA Product Code
- GEX FDA UDIHQF FDA UDI
- GMDN Term
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI886.4390 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General/multiple surgical frequency-doubled solid-state laser system
Endophotocoagulation Delivery Unit by Nidek, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA UDI 62a35754-24a9-4908-8cc7-7db612c36773 34 fields · synced Jun 1, 2026