RootEX standard 1.8 (sample)

GUDID 07630049901421

Endodontic instrument kit for root tip extraction

Diaswiss SA

Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable Endodontic enlarger, reusable
Primary Device ID07630049901421
NIH Device Record Keydef14356-73c7-40a3-97ea-112df5be1d71
Commercial Distribution StatusIn Commercial Distribution
Brand NameRootEX standard 1.8 (sample)
Version Model Number935L.Set018-sam
Company DUNS480296552
Company NameDiaswiss SA
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS107630049901421 [Primary]

FDA Product Code

EKSFILE, PULP CANAL, ENDODONTIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


[07630049901421]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-11
Device Publish Date2023-12-01

On-Brand Devices [RootEX standard 1.8 (sample)]

07630049901483Endodontic instrument kit for root tip extraction
07630049901421Endodontic instrument kit for root tip extraction

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