GT8 Heavy Ball Electrode (2.38mm)

GUDID 04719873121335

BONART CO., LTD.

Electrosurgical system
Primary Device ID04719873121335
NIH Device Record Key5149fdf4-ba70-4cfc-8f7f-325e4e892ab9
Commercial Distribution StatusIn Commercial Distribution
Brand NameGT8 Heavy Ball Electrode (2.38mm)
Version Model NumberGT8
Company DUNS657263687
Company NameBONART CO., LTD.
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719873121335 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKZUnit, Electrosurgical, And Accessories, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


[04719873121335]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-06
Device Publish Date2020-02-27

Devices Manufactured by BONART CO., LTD.

04719873121533 - ART TRIPLE BEND 25kHz2023-04-03
04719873121540 - ART TRIPLE BEND 30kHz2023-04-03
04719873121410 - PIEZO TIP/BE-P2022-03-28
04719873121366 - 25K FS-SLIM PLASTIC INSERT/Darby2021-01-04
04719873121373 - 30K FS-SLIM PLASTIC INSERT/Darby2021-01-04
04719873121380 - 25K FS-10 PLASTIC INSERT/Darby2021-01-04
04719873121397 - 30K FS-10 PLASTIC INSERT/Darby2021-01-04
04719873121359 - BONE TIP/BM-PS12020-09-25

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