Identity
- Trade Name
- Digitalis MCP Rasp EUDAMEDDIGITALIS INSTRUMENTS FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- Strumenti chirurgici riutilizzabili accessori all'impianto dei dispositivi Digitalis EUDAMED
- Model / Reference
- DDGI202001 EUDAMEDDigitalis MCP Rasp FDA UDI
Identifiers
- Catalog Number
- DDGI202001 FDA UDI
- Primary DI / UDI-DI
- 08057717559958 EUDAMEDFDA UDI
- Basic UDI-DI
- 805771755FT08C3C5 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091201 ORTHOPAEDIC SURGERY RASPS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic broach 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: Orthopaedic broach
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 ce032524-5158-4e4e-80b1-e3fa1a6614bd 35 fields · synced Jun 18, 2026
- EUDAMED 637133c3-70bc-44b5-8f60-53851f332ee0 61 fields · synced Jun 18, 2026