EVO FLEX 60040197

GUDID J015600401979

Endodontic instrument for professionnal dental use only

MICRO MEGA

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device IDJ015600401979
NIH Device Record Key59b1b627-fcba-4f9c-b64b-13725ea47c07
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVO FLEX
Version Model NumberN30 4%L25 Sterile
Catalog Number60040197
Company DUNS276075371
Company NameMICRO MEGA
Device Count6
DM Exempttrue
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 Numbertrue
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
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
HIBCCJ015600401970 [Unit of Use]
HIBCCJ015600401971 [Primary]
HIBCCJ015600401979 [Package]
Contains: J015600401971
Package: [10 Units]
In Commercial Distribution

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 Date2025-03-03
Device Publish Date2025-02-21

On-Brand Devices [EVO FLEX]

J015600402049Endodontic instrument for professionnal dental use only
J015600402039Endodontic instrument for professionnal dental use only
J015600402029Endodontic instrument for professionnal dental use only
J015600402019Endodontic instrument for professionnal dental use only
J015600402009Endodontic instrument for professionnal dental use only
J015600401999Endodontic instrument for professionnal dental use only
J015600401989Endodontic instrument for professionnal dental use only
J015600401979Endodontic instrument for professionnal dental use only
J015600401969Endodontic instrument for professionnal dental use only
J015600401959Endodontic instrument for professionnal dental use only
J015600401949Endodontic instrument for professionnal dental use only
J015600401939Endodontic instrument for professionnal dental use only
J015600401929Endodontic instrument for professionnal dental use only
J015600401919Endodontic instrument for professionnal dental use only
J015600401900Endodontic instrument for professionnal dental use only

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