CEFLA 96601030

GUDID 08033837937494

The device is a dental operating light intended to illuminate oral structures and operating areas during dental treatment.

CEFLA SOCIETA' COOPERATIVA

Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light Reflective dental room light

Primary Device ID	08033837937494
NIH Device Record Key	68094cc3-2505-413a-b309-bb4cff4a2371
Commercial Distribution Status	In Commercial Distribution
Brand Name	CEFLA
Version Model Number	VENUS PLUS
Catalog Number	96601030
Company DUNS	429341410
Company Name	CEFLA SOCIETA' COOPERATIVA
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033837937494 [Primary]

FDA Product Code

EAZ	Light, Operating, Dental

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-11-15
Device Publish Date	2023-11-07