ENDO 1500 MID MEDI 50400011

GUDID J015504000110

Dental handpiece for endontic treatment which works with Sonic vibtration

MICRO MEGA

Dental power tool system, pneumatic
Primary Device IDJ015504000110
NIH Device Record Keybd06e880-cf45-448b-acbb-7de9047024c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDO 1500 MID MEDI
Version Model NumberMID
Catalog Number50400011
Company DUNS276075371
Company NameMICRO MEGA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCJ015504000110 [Primary]
HIBCCJ015504000111 [Direct Marking]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[J015504000110]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-13
Device Publish Date2016-09-22

Devices Manufactured by MICRO MEGA

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23701310322691 - EdgeOne-R Utopia R-Glide 2024-04-16 Endodontic instrument for professional dental use only
23701310322707 - EdgeOne-R Utopia R-Glide2024-04-16 Endodontic instrument for professional dental use only
23701310322745 - EdgeOne-R Utopia2024-04-16 Endodontic instrument for professional dental use only
23701310322752 - EdgeOne-R Utopia2024-04-16 Endodontic instrument for professional dental use only
23701310322769 - EdgeOne-R Utopia2024-04-16 Endodontic instrument for professional dental use only
23701310322776 - EdgeOne-R Utopia2024-04-16 Endodontic instrument for professional dental use only
23701310322783 - EdgeOne-R Utopia2024-04-16 Endodontic instrument for professional dental use only

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