Identity
- Trade Name
- Hana/ProFx Femoral Hook Right EUDAMEDFDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- Hana/ProFx Femoral Hook Right EUDAMED
- Model / Reference
- 6850-918 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 6850-918 FDA UDI
- Primary DI / UDI-DI
- 00842430106811 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00842430106811 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0902 ORTHOPAEDIC SURGERY LEVERS, REUSABLE EUDAMED
- GMDN Term
- Bone lever/elevator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Moist Heat or Steam Sterilization FDA UDI
Category: Bone lever/elevator, reusable
Hana/ProFx Femoral Hook Right by Mizuho Orthopedic Systems, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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 430cc1e8-730f-4e7f-b768-1b9f0b82547c 34 fields · synced Jul 12, 2026
- EUDAMED 316a4a2a-92e5-4ea5-9640-8c7dfafd9c04 61 fields · synced Jul 12, 2026