Identity
- Trade Name
- Primado2 FDA UDI
- Generic Name
- Drilling power tool attachment, basic FDA UDI
- Model / Reference
- P200-1A155-U EUDAMEDFDA UDIMDA0000008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04589551365159 EUDAMED04589551365166 FDA UDI
- Basic UDI-DI
- 45602249800000086Z EUDAMED
- Direct Marketing DI
- 04589551365197 EUDAMED
- FDA Product Code
- HBE FDA UDIERL FDA UDIHWE FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Drilling power tool attachment, basic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4310 FDA UDI874.4250 FDA UDI878.4820 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Drilling power tool attachment, basicBurring power tool attachment
Primado2 by Nakanishi Inc. — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
Sources (2)
- FDA UDI b149d619-c207-453d-a37b-3364eed46e62 32 fields · synced Jul 14, 2026
- EUDAMED bbc5b811-aba5-4282-a841-75e259949035 61 fields · synced Jul 14, 2026