Celalux III 9094

GUDID E22190941

High-Power LED curing-light (pool)

VOCO GmbH

Dental/surgical polymerization lamp
Primary Device IDE22190941
NIH Device Record Key71bcbe5a-af13-4c3f-9793-6f90f08bd41c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCelalux III
Version Model Number9094
Catalog Number9094
Company DUNS316699578
Company NameVOCO GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE22190941 [Primary]

FDA Product Code

EBZActivator, Ultraviolet, For Polymerization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-16
Device Publish Date2024-05-08

On-Brand Devices [Celalux III]

E22190931Rubber Shield, accessory to Celalux III
E22190921Device Base, accessory to Celalux III
E22190911Light guide 8 mm, autoclavable, accessory to Celalux III
E22190901High-Power LED curing-light
E22190941High-Power LED curing-light (pool)

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