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Orthopaedic Surgical Instrument - Container
EUDAMEDFDA UDIClass I (EU MDR)
Ref 57-2010
Identity
- Trade Name
- Buxton BioMedical FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Orthopaedic Surgical Instrument - Container EUDAMEDSterilizing Case 15x10x0.75 FDA UDI
- Model / Reference
- 57-2010 EUDAMEDFDA UDI
- Description
- Sterilizing Case 15x10x0.75 FDA UDI
Identifiers
- Catalog Number
- 57-2010 FDA UDI
- Primary DI / UDI-DI
- +B76857201002 EUDAMEDB7685720100 FDA UDI
- Basic UDI-DI
- ++B768TF5TM 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 553d05be-6fc0-4306-8af3-8762103562cf 61 fields · synced Jun 18, 2026
- FDA UDI d366ab39-d5c1-4f49-a8ed-454d6ea5d64e 34 fields · synced May 30, 2026