Celalux III 9092

GUDID E22190921

Device Base, accessory to Celalux III

VOCO GmbH

Dental/surgical polymerization lamp
Primary Device IDE22190921
NIH Device Record Key670d3bd0-f695-41a1-adbe-cded29a0733a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCelalux III
Version Model Number9092
Catalog Number9092
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 Datefalse
Expiration Datetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE22190921 [Primary]

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 Date2016-08-31

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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