Identity
- Trade Name
- BLUE 400 FDA UDI
- Generic Name
- Neurosurgical microscope FDA UDI
- Device Name
- for OPMI PENTERO 800 and OPMI PENTERO 900 FDA UDI
- Model / Reference
- 302581-9050-000 FDA UDI
- Description
- for OPMI PENTERO 800 and OPMI PENTERO 900 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539104342 FDA UDI
- FDA Product Code
- FSO FDA UDI
- GMDN Term
- Neurosurgical 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Neurosurgical microscope
Blue 400 by Carl Zeiss Meditec AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Surgical Microscope MM80/YOH — MITAKA KOHKI CO., LTD. · Class I
- Surgical Microscope MM80/SS1 — MITAKA KOHKI CO., LTD. · Class I
- Surgical Microscope MM51/SS1 — 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
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI fe2b1cab-178f-4fa6-b8a3-cb679149d082 33 fields · synced May 30, 2026