ISRIE

GUDID 06975043365987

Nickel Titanium Root Canal File 6 psc/pack Including G3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3-G2506-25, G3-G3504-25.

Hansfive (Hangzhou) Dental Technology Co.,Ltd.

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID06975043365987
NIH Device Record Key26e5ca23-e071-4edf-bd37-ee8dac06aa04
Commercial Distribution StatusIn Commercial Distribution
Brand NameISRIE
Version Model NumberG3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3
Company DUNS413885255
Company NameHansfive (Hangzhou) Dental Technology Co.,Ltd.
Device Count1
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
GS106975043365987 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


[06975043365987]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-15
Device Publish Date2026-01-07

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