VarioSurg-HP

GUDID 04560264508491

NAKANISHI INC.

Dental ultrasonic surgical system
Primary Device ID04560264508491
NIH Device Record Keyf3fa4fa2-7184-4aad-945e-10bd3e798f28
Commercial Distribution StatusIn Commercial Distribution
Brand NameVarioSurg-HP
Version Model NumberVarioSurg-HP
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
GS104560264508491 [Primary]
GS104560264557260 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


[04560264508491]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-23
Device Publish Date2016-09-16

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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