Identity
- Trade Name
- Surgical 3D Video Microscope KestrelView II FDA UDI
- Generic Name
- Surgical microscope fluorescent angiography system FDA UDI
- Device Name
- The KV2 is for use as surgical microscope designed to magnify minute structuresin the fields for surgery. FDA UDI
- Model / Reference
- KV2 FDA UDI
- Description
- The KV2 is for use as surgical microscope designed to magnify minute structuresin the fields for surgery. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04589698450206 FDA UDI
- FDA Product Code
- EPT FDA UDI
- GMDN Term
- Surgical microscope fluorescent angiography system 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
No
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
No
FDA UDI
Category: General-purpose surgical microscopeENT surgical microscopeNeurosurgical microscopeSurgical microscope fluorescent angiography system
Surgical 3D Video Microscope KestrelView II by Mitaka Kohki Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Surgical Microscope MM51/SOH — MITAKA KOHKI CO., LTD. · Class I
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
- Mitaka Kohki Co., Ltd.
Sources (1)
- FDA UDI ce95be3b-e296-4562-b9f6-741a80909d43 33 fields · synced Jun 8, 2026