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Clearfix
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 253113Model General Orthopedic Use Pins and Screws
Identity
- Trade Name
- CLEARFIX Calibration Tool EUDAMEDCLEARFIX FDA UDI
- Generic Name
- Orthopaedic implant calibration pin FDA UDI
- Device Name
- Thumb Screw, Calibration Tool, Straight, Femoral, Tibial, Rigidfix EUDAMEDCLEARFIX Calibration Tool Straight FDA UDI
- Model / Reference
- 253113 EUDAMEDFDA UDIGeneral Orthopedic Use Pins and Screws EUDAMED
- Description
- CLEARFIX Calibration Tool Straight FDA UDI
Identifiers
- Catalog Number
- 253113 FDA UDI
- Primary DI / UDI-DI
- 10886705012640 EUDAMEDFDA UDI
- Basic UDI-DI
- 0886705a00130K5 EUDAMED
- Direct Marketing DI
- 10886705012640 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic implant calibration pin 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: Orthopaedic implant calibration pin
Clearfix 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 37a08a02-ab8e-4861-b547-7fc721bb9884 35 fields · synced Jun 20, 2026
- EUDAMED 7e3c73de-302e-4d97-8f62-9c56f2370d77 61 fields · synced Jun 20, 2026