Identity
- Trade Name
- STRATOS EUDAMEDThree-point bending pliers for rib clips, 18 cm FDA UDI
- Generic Name
- Rib/rib cage internal fixation/bracing system bending pliers FDA UDI
- Device Name
- Instrumente Ir Strasbourg Thoracic Osteosynthesis EUDAMED
- Model / Reference
- 010-00020 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 010-00020 FDA UDI
- Primary DI / UDI-DI
- 04260029580693 EUDAMEDFDA UDI
- Basic UDI-DI
- 426002958MEDXPERT-STRS99 EUDAMED
- Direct Marketing DI
- 04260029580693 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Rib/rib cage internal fixation/bracing system bending pliers FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
EUDAMED
CMR Substance
No
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
Stratos by MedXpert GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426002958MEDXPERT-STRS99 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MedXpert GmbH
- EUDAMED SRN
- DE-MF-000005489
Sources (2)
- EUDAMED e546e8a8-aec2-49af-99ba-e9bd53c6a7c5 61 fields · synced Jun 1, 2026
- FDA UDI 3ff81e84-6491-4f39-ba55-2478bfe4bf79 34 fields · synced May 30, 2026