Identity
- Trade Name
- Trios Radiolucent Imaging Top Cover FDA UDI
- Generic Name
- Medical equipment/instrument drape, reusable FDA UDI
- Model / Reference
- 7803-320 FDA UDI
Identifiers
- Catalog Number
- 7803-320 FDA UDI
- Primary DI / UDI-DI
- 00842430104183 FDA UDI
- FDA Product Code
- JEA FDA UDI
- GMDN Term
- Medical equipment/instrument drape, reusable 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical equipment/instrument drape, reusable
Trios Radiolucent Imaging Top Cover by Mizuho Orthopedic Systems, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mizuho Orthopedic Systems, Inc.
Sources (2)
- FDA UDI 805c6e7f-3901-49de-8956-7a6cd6b14e5e 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026