Identity
- Trade Name
- TABLE, ProFx, 230 VOLT FDA UDI
- Generic Name
- Orthopaedic operating table, electromechanical FDA UDI
- Model / Reference
- 6850i FDA UDI
Identifiers
- Catalog Number
- 6850i FDA UDI
- Primary DI / UDI-DI
- 00842430107467 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Orthopaedic operating table, electromechanical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4960 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
Yes
FDA UDI
Category: Orthopaedic operating table, electromechanical
TABLE, ProFx, 230 VOLT by Mizuho Orthopedic Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic operating table, electromechanical.
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- ADVANCED TABLE, OPERATING-ROOM, ELECTRICAL — ADVANCED INSTRUMENTATIONS, INC. · Class I
- ADVANCED TABLE, OPERATING-ROOM, ELECTRICAL — ADVANCED INSTRUMENTATIONS, INC. · Class I
- ADVANCED TABLE, OPERATING-ROOM, ELECTRICAL — ADVANCED INSTRUMENTATIONS, INC. · Class I
- TABLE, ProFx, REFURBISHED — Mizuho Orthopedic Systems, Inc. · Class I
- Adante AX Orthopedic Surgical Platform — Mizuho Orthopedic Systems, Inc. · Class I
- ASSY, BASE & TABLE TOP, ProFx INTL — Mizuho Orthopedic Systems, Inc. · Class I
- TABLE, HANA, 100V JAPAN — Mizuho Orthopedic Systems, Inc. · 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
- Mizuho Orthopedic Systems, Inc.
Sources (1)
- FDA UDI 7df4683a-4ff6-421b-bd50-954b26f6b542 35 fields · synced Jun 9, 2026