Henry ScheinMaxima 1126227

GUDID 10304040054236

MAXIMA RU1200 CURING LIGHT

HENRY SCHEIN, INC.

Dental/surgical polymerization lamp
Primary Device ID10304040054236
NIH Device Record Key51c7a9d2-4657-4d80-8971-3cd1642341d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHenry ScheinMaxima
Version Model Number1126227
Catalog Number1126227
Company DUNS012430880
Company NameHENRY SCHEIN, INC.
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 Usetrue
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

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween -30 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040054239 [Primary]
GS110304040054236 [Package]
Contains: 00304040054239
Package: [12 Units]
In Commercial Distribution

FDA Product Code

EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-21

On-Brand Devices [Henry ScheinMaxima]

10304040054274MAXIMA 2000 Hight Output Curing Light
10304040054236MAXIMA RU1200 CURING LIGHT

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