Primado2

GUDID 04560264560994

NAKANISHI INC.

Multi-purpose surgical power tool system, line-powered
Primary Device ID04560264560994
NIH Device Record Key792d787c-21c2-4c2f-87b7-0651854ccc56
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrimado2
Version Model NumberP200-2AES
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104560264560994 [Primary]
GS104589551352043 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBCMOTOR, DRILL, ELECTRIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


[04560264560994]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-22
Device Publish Date2016-09-16

On-Brand Devices [Primado2]

04589551350421P200-CRA
04560264561519P200-3MC
04560264561502PD-CRD-L
04560264561496PD-CRD-M
04560264561489PD-CRD-P
04560264561472P200-CA-4
04560264561465P200-RA330-L
04560264561458PD-RA155
04560264561441PD-RA135
04560264561434P200-RA155
04560264561427P200-RA135
04560264561410P200-1A135
04560264561403PD-RA-H
04560264561397PD-RA-M
04560264561380PD-CA-64
04560264561373PD-2ADM
04560264561366P200-3GAS
04560264561359PD-1A135
04560264561342P200-OSC-S-HS
04560264561335P200-REC-S-HS
04560264561328PD-RA-T
04560264561311P200-RA330
04560264561304PD-SA-R
04560264561298PD-2SM
04560264561281PD-2AL
04560264561274P200-1A175
04560264561267P200-1A155
04560264561250P200-2SL
04560264561243PD-DA-K
04560264561236PD-1A175-10
04560264561229PD-1A155-10
04560264561212PD-RA330-L
04560264561205PD-2AD
04560264561199P200-SAG-S-HS
04560264561182P200-2SMS
04560264561175PD-RA330
04560264561168P200-1A175-C
04560264561151PD-2SS
04560264561144PD-CA-16
04560264561137P200-3GAL
04560264561120P200-HMH-HS
04560264561113P200-BMH-HS
04560264561106PD-2AM
04560264561090PD-2SDM
04560264561083P200-2AMS
04560264561076PD-RA-A
04560264561069P200-2SM
04560264561052PD-DA-J4
04560264561045P200-SAG
04560264561038PD-2AS

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