Identity
- Trade Name
- Digitalis MCP Reamer EUDAMEDDIGITALIS INSTRUMENTS FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Device Name
- Strumenti chirurgici riutilizzabili accessori all'impianto dei dispositivi Digitalis EUDAMED
- Model / Reference
- DDGI201001 EUDAMEDDigitalis MCP Reamer FDA UDI
Identifiers
- Catalog Number
- DDGI201001 FDA UDI
- Primary DI / UDI-DI
- 08057717559972 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771755FT08C3C5 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Bone-resection orthopaedic reamer, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Italy 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
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
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
Category: Bone-resection orthopaedic reamer, reusable
Digitalis Instruments by Brm Extremities — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brm Extremities
Sources (2)
- FDA UDI 817c0a1e-eae8-4495-abfc-b12decefe308 35 fields · synced Jul 16, 2026
- EUDAMED d50c3594-e158-4aa5-a184-9af6b930d728 61 fields · synced Jul 16, 2026