Reamer 31mm 45 - 80, pu: 6 pcs

GUDID 07630049901537

Manual instrument for endodontic intraoral use

Diaswiss SA

Manual endodontic file/rasp, reusable
Primary Device ID07630049901537
NIH Device Record Key7418a6a7-1f79-4471-b096-5facd6c9f5a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameReamer 31mm 45 - 80, pu: 6 pcs
Version Model Number231031.4580
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
GS107630049901537 [Primary]

FDA Product Code

EKPREAMER, PULP CANAL, ENDODONTIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

Moist Heat or Steam Sterilization


[07630049901537]

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

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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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