ONE FLARE 20952201

GUDID J015209522011

Endodontic instrument for professionnal dental use only

MICRO MEGA

Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable
Primary Device IDJ015209522011
NIH Device Record Key293e5c44-0ed7-4b25-977a-4bc939624f29
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE FLARE
Version Model Numbern25 9% L17 Classics sterile
Catalog Number20952201
Company DUNS276075371
Company NameMICRO MEGA
Device Count5
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522010 [Unit of Use]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522011 [Primary]
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution
HIBCCJ015209522012 [Package]
Package: Grouping box [10 Units]
In Commercial Distribution

FDA Product Code

EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic
EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


[J015209522011]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

Devices Manufactured by MICRO MEGA

J015201020011 - K FILES2020-07-31 Endodontic instruments for professionnal use only
J015201210021 - PASTINJECT2020-07-31 Endodontic instrument for professionnal dental use only
J015209492011 - ONE SHAPE APICAL2020-07-31 Endodontic instrument for professionnal dental use only
J015209522011 - ONE FLARE2020-07-31Endodontic instrument for professionnal dental use only
J015209522011 - ONE FLARE2020-07-31 Endodontic instrument for professionnal dental use only
J015504000110 - ENDO 1500 MID MEDI2019-06-13 Dental handpiece for endontic treatment which works with Sonic vibtration

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