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Stracos
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 014-01012Ref 014-01009Ref 014-02013
Identity
- Trade Name
- STRACOS EUDAMEDTitanium 3D rib clip, 13 segments, XL FDA UDITitanium 3D rib clip, 9 segments FDA UDI
- Generic Name
- Rib/rib cage internal fixation/bracing system fixation grip/anchor FDA UDI
- Device Name
- Titan 3D-Rippenklammer, 12 Segmente EUDAMEDTitan 3D-Rippenklammer, 9 Segmente EUDAMED014-02013 Titan 3D-Rippenklammer, 13 Segmente, XL EUDAMED
- Model / Reference
- 014-01012 EUDAMED014-02013 EUDAMEDFDA UDI014-01009 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 014-02013 FDA UDI014-01009 FDA UDI
- Primary DI / UDI-DI
- 04260029586688 EUDAMED04260029581737 EUDAMEDFDA UDI04260029580921 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260029586688 EUDAMEDB-04260029580921 EUDAMEDB-04260029581737 EUDAMED
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120299 OSTEOSYNTHESIS NAILS - OTHER EUDAMED
- GMDN Term
- Rib/rib cage internal fixation/bracing system fixation grip/anchor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
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
No
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
Stracos by MedXpert GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260029586688 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- MedXpert GmbH
- EUDAMED SRN
- DE-MF-000005489
Sources (5)
- EUDAMED 755c3156-9ddd-4e04-9e65-bf825ef841a0 61 fields · synced Aug 1, 2026
- FDA UDI b9c4d796-60d4-42be-a4ce-2a49270661ca 34 fields · synced May 30, 2026
- FDA UDI 10fd088c-6f52-43c4-854a-8a75a8ea7dca 34 fields · synced May 30, 2026
- EUDAMED 0206487f-8d07-4e32-8650-67e7e2c643bf 61 fields · synced Jul 9, 2026
- EUDAMED a88f1f19-0d74-413f-8b4f-7d9f4ed2c03d 61 fields · synced Aug 1, 2026