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Primado2

FDA UDI

Class II (US FDA UDI)

by Nakanishi Inc.

Identity

Trade Name
Primado2 FDA UDI
Generic Name
Multi-purpose surgical power tool system, line-powered FDA UDI
Model / Reference
PD-RA135 FDA UDI

Identifiers

Primary DI / UDI-DI
04560264561441 FDA UDI
510(k) Number
K132264 FDA UDI
FDA Product Code
HBC FDA UDI
GMDN Term
Multi-purpose surgical power tool system, line-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4360 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Primado2 by Nakanishi Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K132264 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nakanishi Inc.

Sources (1)

  • FDA UDI 0116f597-b93b-4bad-a458-4cd806d8d783 34 fields · synced Jun 8, 2026