VaryFlex Neo, 20/04, 25mm

GUDID 05060940378725

ENDOPERFECTION LIMITED

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID05060940378725
NIH Device Record Key0f58c4b3-5e80-41df-a98e-fd28f0e49b5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVaryFlex Neo, 20/04, 25mm
Version Model NumberVFNEO200425
Company DUNS224419290
Company NameENDOPERFECTION LIMITED
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060940378725 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-08
Device Publish Date2024-03-29

Devices Manufactured by ENDOPERFECTION LIMITED

05060940379418 - VaryFlex OR, VFOR, 20/07, 19mm2025-04-10
05060940376905 - VaryFlex Neo, 30/04, 25mm2024-04-12
05060940376912 - VaryFlex Neo, 35/04, 25mm2024-04-12
05060940376929 - VaryFlex Neo, 40/04, 25mm2024-04-12
05060940376936 - VaryFlex Neo, 50/04, 25mm2024-04-12
05060940376943 - VaryFlex Neo, 15/04, 31mm2024-04-12
05060940376950 - VaryFlex Neo, 25/04, 31mm2024-04-12
05060940376967 - VaryFlex Neo, 30/04, 31mm2024-04-12

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.