EdgeOne-R Utopia EORUA25Sv2

GUDID 23701310322752

Endodontic instrument for professional dental use only

MICRO MEGA

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID23701310322752
NIH Device Record Keyf2c47394-7905-4358-ba4d-aec512fd6ff9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdgeOne-R Utopia
Version Model NumberAsst v2 L25 Sterile
Catalog NumberEORUA25Sv2
Company DUNS276075371
Company NameMICRO MEGA
Device Count1
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS103701310322758 [Primary]
GS123701310322752 [Package]
Contains: 03701310322758
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 Date2024-04-16
Device Publish Date2024-04-08

On-Brand Devices [EdgeOne-R Utopia]

23701310370364Endodontic instrument for professional dental use only
23701310370357Endodontic instrument for professional dental use only
23701310370340Endodontic instrument for professional dental use only
23701310370333Endodontic instrument for professional dental use only
23701310370326Endodontic instrument for professional dental use only
23701310370319Endodontic instrument for professional dental use only
23701310370302Endodontic instrument for professional dental use only
23701310370296Endodontic instrument for professional dental use only
23701310370289Endodontic instrument for professional dental use only
23701310370272Endodontic instrument for professional dental use only
23701310370265Endodontic instrument for professional dental use only
23701310370258Endodontic instrument for professional dental use only
23701310322790Endodontic instrument for professional dental use only
23701310322783Endodontic instrument for professional dental use only
23701310322776Endodontic instrument for professional dental use only
23701310322769Endodontic instrument for professional dental use only
23701310322752Endodontic instrument for professional dental use only
23701310322745Endodontic instrument for professional dental use only

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