Kerator Magic Tool

GUDID 08809488213405

KJMEDITECH.CO.,LTD

Dental torque wrench
Primary Device ID08809488213405
NIH Device Record Key646d95bd-ab15-4cfe-99f3-a98bbf99c34b
Commercial Distribution StatusIn Commercial Distribution
Brand NameKerator Magic Tool
Version Model NumberKMT002
Company DUNS688476027
Company NameKJMEDITECH.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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS108809488213405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


[08809488213405]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-18
Device Publish Date2019-08-28

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08809488210138 - ANCHOR PLUS/NEO ANCHOR PLUS2024-01-03

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