Identity
- Trade Name
- STRATOS EUDAMEDTitanium Sternum Triple-clip L FDA UDI
- Generic Name
- Sternal fixation device FDA UDI
- Device Name
- 015-01330 Titan Sternum Tripel-Klammer L EUDAMED
- Model / Reference
- 015-01330 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 015-01330 FDA UDI
- Primary DI / UDI-DI
- 04260029583151 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260029583151 EUDAMED
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120299 OSTEOSYNTHESIS NAILS - OTHER EUDAMED
- GMDN Term
- Sternal fixation device 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
Stratos 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-04260029583151 | 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 (2)
- EUDAMED 05905194-7f3b-4910-a5b7-cbad1878f479 61 fields · synced Jul 9, 2026
- FDA UDI a4ede5dd-f2c3-4c03-bda9-05c4367559c0 34 fields · synced May 30, 2026