FDA.reportPublic FDA data

CEFLA

Primary DI
08033837937494
Brand
CEFLA
Company
CEFLA SOCIETA' COOPERATIVA
Model
VENUS PLUS
Catalog number
96601030
Device description
The device is a dental operating light intended to illuminate oral structures and operating areas during dental treatment.
Published
2023-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EAZLight, Operating, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAZLight, Operating, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033837937494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033837937494080338379374948033837937494

GMDN Terms#

Term, Definition table
TermDefinition
Reflective dental room lightA mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light typically into or around the oral cavity of a patient to illuminate the site of a dental examination or procedure. It is constructed as a curved reflector with a dedicated central light bulb that produces and focuses the light, an outer housing with handles for dental staff to hold when manoeuvring the light head, and a jointed support arm. This device may be incorporated into a dental delivery system or be fixed separately to the ceiling or other support.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Handling Environment Temperature25 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429341410
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033837933021CEFLAVENUS PLUS966010702026-10-13
08033837933045CEFLAVENUS PLUS966010902026-10-13
08033837938583CEFLAVENUS PLUS966010402026-10-13
08033837938606CEFLAVENUS PLUS966010412026-10-13
08033837938644CEFLAVENUS PLUS966011002026-10-13
08033837938682CEFLAVENUS PLUS966011012026-10-13
08033837938699CEFLAVENUS PLUS966010422026-10-13
08033837938705CEFLAVENUS PLUS966010432026-10-13
08033837938712CEFLAVENUS PLUS966010302026-10-13
08033837938729CEFLAVENUS PLUS966011022026-10-13
08033837938736CEFLAVENUS PLUS966010322026-10-13
08033837938743CEFLAVENUS PLUS966010332026-10-13
08033837938835no brandNeowise7XPD2026-05-11
08033837935889Anthosi-MMs FLUO955206732026-04-16
08033837935896Anthosi-MMr L FLUO955206722026-04-16
08033837935902Stern Weberi-XS4 FLUO955206752026-04-16
08033837935919Stern Weberi-XR3 L FLUO955206742026-04-16
08033837935926Castelliniimplantor LED FLUO955206772026-04-16
08033837935933Castellinihandy power LED FLUO955206762026-04-16
08033837938316CEFLAAPEX LOCATOR760002012026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719965090020LED Operating LightCHUAN FU MEDICAL INSTRUMENT CO., LTD.EAZ2026-10-22
08033837933021CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837933045CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938583CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938606CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938644CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938682CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938699CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938705CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938712CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938729CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938736CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938743CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
00841709125638MidmarkMIDMARK CORPORATIONEAZ2026-07-08
00840456221372JMUJMU DENTAL, INCEAZ2026-07-06
00840456221389JMUJMU DENTAL, INCEAZ2026-07-06
00840456221396JMUJMU DENTAL, INCEAZ2026-07-06
00840456221402JMUJMU DENTAL, INCEAZ2026-07-06
00840456221419JMUJMU DENTAL, INCEAZ2026-07-06
00840456221426JMUJMU DENTAL, INCEAZ2026-07-06
00841709121920MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122088MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122217MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709121906MidmarkMIDMARK CORPORATIONEAZ2026-03-18
00841709121913MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121937MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121944MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121951MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121968MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121975MidmarkMIDMARK CORPORATIONEAZ2026-03-10