FDA.reportPublic FDA data

OPTIMAX

Primary DI
04260502640029
Brand
OPTIMAX
Company
PROTEC GmbH & Co. KG
Model
1170
Catalog number
1170-9-8000
Device description
Darkroom automated x-ray film processor
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IXWProcessor, Radiographic-Film, Automatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXWProcessor, Radiographic-Film, AutomaticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260502640029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260502640029042605026400294260502640029

GMDN Terms#

Term, Definition table
TermDefinition
Darkroom automated x-ray film processorA mains electricity (AC-powered) automated darkroom film processing device in which x-ray/radiographic film must be manually removed from a cassette and loaded into the processor in a darkroom setting. It is designed to transport x-ray or radiographic film from one solution to the next in the developing process without any manual labour except the insertion of the film. It has typically six main sub-systems: transport, temperature, circulation, replenishment, drying and electrical control.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity50 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314629130
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260502640357PROGNOST XStable top 196,3x65,5cm composite fiber7034-0-00002020-12-15
04260502640203PROGNOST XPtable top 200x65,5cm composite fiber7036-0-17102020-12-15
04260502640210PROGNOST XPtable top 200x75,5cm composite fiber7036-0-17112020-12-15
04260502640227PROGNOST XPtable top 226x75,5cm composite fiber7036-0-17122020-12-15
04260502640234PROGNOST XPtable top 200x75,5cm, carbon fiber7036-0-17132020-12-15
04260502640241PROGNOST XPtable top 226x75,5cm carbon fiber7036-0-17142020-12-15
04260502640258PROGNOST XPEtable top 200x65,5cm composite fiber7037-6-17102020-12-15
04260502640265PROGNOST XPEtable top 200x75,5cm composite fiber7037-6-17112020-12-15
04260502640272PROGNOST XPEtable top 226x75,5cm composite fiber7037-6-17122020-12-15
04260502640289PROGNOST XPEtable top 200x75,5cm, carbon fiber7037-6-17132020-12-15
04260502640296PROGNOST XPEtable top 226x75,5cm carbon fiber7037-6-17142020-12-15
04260502640302PROGNOST XPE-Akkutable top 200x65,5cm composite fiber7038-9-17102020-12-15
04260502640319PROGNOST XPE-Akkutable top 200x75,5cm composite fiber7038-9-17112020-12-15
04260502640326PROGNOST XPE-Akkutable top 226x75,5cm composite fiber7038-9-17122020-12-15
04260502640333PROGNOST XPE-Akkutable top 200x75,5cm, carbon fiber7038-9-17132020-12-15
04260502640340PROGNOST XPE-Akkutable top 226x75,5cm carbon fiber7038-9-17142020-12-15
04260502640043PROGNOST XS7034-0-00002016-10-28
04260502640050PROGNOST XP7036-0-1703L2016-10-28
04260502640067PROGNOST XPE7037-1-1703L2016-10-28
04260502640074PROGNOST XPE-Akku7038-9-1703L2016-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060209580777IntraX Film ProcessorMEDIVANCE INSTRUMENTS LIMITEDIXW2022-08-06
05060209580814ExtraXtender Film ProcessorMEDIVANCE INSTRUMENTS LIMITEDIXW2022-08-06
B580IWX0Mini MedAFP MANUFACTURING, INC.IXW2019-06-19
08809413810181Automatic Radiographic Film ProcessorJPI HEALTHCARE. CO., LTD.IXW2017-08-01
04260502640005COMPACT 2PROTEC GmbH & Co. KGIXW2016-10-28
04260502640012ECOMAXPROTEC GmbH & Co. KGIXW2016-10-28
04260502640036OPTIMAX 2010PROTEC GmbH & Co. KGIXW2016-10-28
D678450000A/T 2000 XR Intraoral Film ProcessorAIR TECHNIQUES, INC.IXW2016-09-23
D678450040A/T 2000 XR Intraoral Film Processor with Water Recirculation SystemAIR TECHNIQUES, INC.IXW2016-09-23
D678940000Peri-Pro III Intraoral Film ProcessorAIR TECHNIQUES, INC.IXW2016-09-23