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Rigidfix
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 213705Model General Orthopedic Use Mallets
Identity
- Trade Name
- RIGIDFIX Mallet EUDAMEDRIGIDFIX FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- Mallet, RIGIDFIX, RESTORE EUDAMEDRIGIDFIX Mallet FDA UDI
- Model / Reference
- 213705 EUDAMEDFDA UDIGeneral Orthopedic Use Mallets EUDAMED
- Description
- RIGIDFIX Mallet FDA UDI
Identifiers
- Catalog Number
- 213705 FDA UDI
- Primary DI / UDI-DI
- 10886705002993 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00127KG EUDAMED
- Direct Marketing DI
- 10886705002993 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical mallet FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium 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
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical mallet
Rigidfix by Medos International Sàrl — 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
- Medos International Sàrl
Sources (2)
- FDA UDI 240bca09-268a-4115-8e37-f6d25250d1d2 35 fields · synced Jul 13, 2026
- EUDAMED f1b08767-2b58-4aed-985a-5d6fbda5e50f 61 fields · synced Jul 13, 2026