Identity
- Trade Name
- AQUARI SURFACE STERIS 4085, 5085 3-PC FDA UDI
- Generic Name
- Operating table patient pressure distribution monitoring/regulation system FDA UDI
- Model / Reference
- 246-4085 FDA UDI
Identifiers
- Catalog Number
- 246-4085 FDA UDI
- Primary DI / UDI-DI
- 00842430115769 FDA UDI
- FDA Product Code
- FNM FDA UDI
- GMDN Term
- Operating table patient pressure distribution monitoring/regulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5550 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating table patient pressure distribution monitoring/regulation system
Aquari Surface Steris 4085, 5085 3-Pc by Mizuho Orthopedic Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operating table patient pressure distribution monitoring/regulation system.
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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
- Mizuho Orthopedic Systems, Inc.
Sources (1)
- FDA UDI cdcb3242-3ad0-4aaf-a60d-f3da7b859679 34 fields · synced Jun 9, 2026