Lentulo, 35, 29

GUDID 05060940375809

ENDOPERFECTION LIMITED

Endodontic obturation material distribution endpiece, reusable
Primary Device ID05060940375809
NIH Device Record Key29621668-ba6f-4c67-b05f-6d5b2f51b96d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLentulo, 35, 29
Version Model NumberEPC2935
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 Usefalse
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
GS105060940375809 [Primary]

FDA Product Code

EKPReamer, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


[05060940375809]

Moist Heat or Steam Sterilization


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

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