Identity
- Trade Name
- Protection Plug FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Model / Reference
- MDA0000028 EUDAMED10001595 EUDAMEDProtection Plug FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560264576506 EUDAMEDFDA UDI
- Basic UDI-DI
- 456022498000002877 EUDAMED
- 510(k) Number
- K233117 FDA UDI
- FDA Product Code
- EBW FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Germany 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
10001595 by Nakanishi Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 456022498000002877 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
- EUDAMED SRN
- JP-MF-000011271
- Authorised Representative
- NSK Europe GmbH DE-AR-000007040
Sources (2)
- EUDAMED d6468430-c68c-4edf-a2f9-655ea29a0b3f 61 fields · synced Jul 10, 2026
- FDA UDI f9c9455b-50ca-417c-b284-e123e019d8b3 33 fields · synced May 22, 2026