Identity
- Trade Name
- pde-neoII FDA UDI
- Generic Name
- Surgical microscope fluorescent angiography system FDA UDI
- Model / Reference
- C10935-400 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582389010543 FDA UDI
- 510(k) Number
- K133719 FDA UDI
- FDA Product Code
- IZI FDA UDIOWN FDA UDI
- GMDN Term
- Surgical microscope fluorescent angiography system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1600 FDA UDI876.1500 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical microscope fluorescent angiography system
pde-neoII by Hamamatsu Photonics K.K. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical microscope fluorescent angiography system.
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- Modus IR — Synaptive Medical Inc · Class II
- AEOS — AESCULAP, INC. · Class II
- LEICA FL800 — Leica Microsystems (Schweiz) AG · Class II
- INFRARED 800 with FLOW® 800 Option — Carl Zeiss Meditec AG · Class II
Cleared under the same submission
K133719 also covers:
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
- Hamamatsu Photonics K.K.
Sources (1)
- FDA UDI 1ea75f18-0aa6-4ffd-b2d1-109ce237e61d 33 fields · synced May 30, 2026