Applicator brush (endo)

GUDID EKUR001025KA0

KURARAY NORITAKE DENTAL INC.

Surgical retraction system mounting frame, reusable
Primary Device IDEKUR001025KA0
NIH Device Record Key0228e88b-8c00-45b1-8cbd-d7d87d7d3c5f
Commercial Distribution StatusIn Commercial Distribution
Brand NameApplicator brush (endo)
Version Model Number#1025-KA
Company DUNS697119498
Company NameKURARAY NORITAKE DENTAL INC.
Device Count50
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKUR001025KA0 [Unit of Use]
HIBCCEKUR001025KA1 [Primary]

FDA Product Code

KXRApplicator, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-03
Device Publish Date2024-08-26

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