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Orthopaedic Surgical Instrument - Container
EUDAMEDFDA UDIClass I (EU MDR)
Ref 54-5191
Identity
- Trade Name
- Buxton Biomedical FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Orthopaedic Surgical Instrument - Container EUDAMEDCase for Tenolysis Instruments FDA UDI
- Model / Reference
- 54-5191 EUDAMEDFDA UDI
- Description
- Case for Tenolysis Instruments FDA UDI
Identifiers
- Catalog Number
- 54-5191 FDA UDI
- Primary DI / UDI-DI
- +B7685451910C EUDAMEDB7685451910 FDA UDI
- Basic UDI-DI
- ++B768TF5TM EUDAMED
- Direct Marketing DI
- +B7685451910C EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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
No
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
No
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: Instrument tray, reusable
Orthopaedic Surgical Instrument - Container by Buxton Biomedical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | ++B768TF5TM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Buxton BioMedical, inc.
- EUDAMED SRN
- US-MF-000035059
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 4dfbc39e-5d4e-4924-aec7-edc36c82547a 61 fields · synced Jul 18, 2026
- FDA UDI ec7c7327-4fac-4b9d-bfb0-54b981029159 34 fields · synced May 29, 2026