rootEX instrument set short, pu: 2 pcs

GUDID 07630049950894

Rotary instrument for endodontic intraoral use

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 ID07630049950894
NIH Device Record Keya1fab8a2-e737-472d-85a8-94e63f166112
Commercial Distribution StatusIn Commercial Distribution
Brand NamerootEX instrument set short, pu: 2 pcs
Version Model Number937K.Set
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
GS107630049950894 [Primary]

FDA Product Code

EKSFILE, PULP CANAL, ENDODONTIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

Moist Heat or Steam Sterilization


[07630049950894]

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

Devices Manufactured by Diaswiss SA

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07630049901100 - A-Z Modern Cavity Set2023-12-11 Dental application set for intraoral use
07630049901391 - RootEX standard 0.8 (sample)2023-12-11 Endodontic instrument kit for root tip extraction
07630049901407 - RootEX standard 011(sample)2023-12-11 Endodontic instrument kit for root tip extraction
07630049901414 - RootEX standard 1.6 (sample)2023-12-11 Endodontic instrument kit for root tip extraction
07630049901421 - RootEX standard 1.8 (sample)2023-12-11 Endodontic instrument kit for root tip extraction
07630049901438 - RootEX standard 0.8 (sample)2023-12-11 Endodontic instrument kit for root tip extraction

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