Surgic Pro2 NON-OPT

GUDID 04589551389407

NAKANISHI INC.

Foot-switch, electrical
Primary Device ID04589551389407
NIH Device Record Key82aad19a-68bd-4d9c-bb2d-ffd015111f1c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgic Pro2 NON-OPT
Version Model NumberSurgic Pro2 NON-OPT
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 Datetrue
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
GS104589551389407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBWController, foot, handpiece and cord

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


[04589551389407]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-23
Device Publish Date2024-10-15

Devices Manufactured by NAKANISHI INC.

04560264575158 - Nozzle Holder2024-11-25
04560264575165 - Nozzle Holder2024-11-25
04560264575172 - Internal Spray Nozzle2024-11-25
04560264575189 - Cleaning Wire2024-11-25
04560264575271 - Tube Holder2024-11-25
04560264576506 - Protection Plug2024-11-25
04560264576513 - Coolant Solution Hanger Post2024-11-25
04589551392421 - Tube Holder2024-11-25

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