FDA.reportPublic FDA data

Chromophare F300

Primary DI
07613327296143
Brand
Chromophare F300
Company
Berchtold Holding GmbH
Model
CG2903175
Catalog number
CG 2903175
Device description
Berchtold Examination Light ? Wall Mounted
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KZFDEVICE, MEDICAL EXAMINATION, AC POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZFDevice, Medical Examination, Ac PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327296143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327296143076133272961437613327296143

GMDN Terms#

Term, Definition table
TermDefinition
Fixed examination/treatment lightA fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316153824
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327169980OperonOT 7701075OT 77010752019-08-27
07613327170047OperonOT 8204675OT 82046752019-08-27
07613327170085OperonOT 8302175OT 83021752019-08-21
07613327170146OperonOT 8602175OT 86021752019-08-21
07613327170269OperonOT 8601175OT 86011752019-08-21
07613327296167ChromophareCH00000001CH000000012016-09-23
07613327459524NAOZ 1509900OZ 15099002021-05-25
07613327170030OperonOT 7606575OT 76065752019-08-27
07613327296228ChromophareCM00000001CM000000012016-09-23
07613327170009OperonOT 8204575OT 82045752019-08-27
07613327296259ChromophareCW00000001CW000000012016-09-23
07613327616545SircaCE3863075CE 38630752023-07-14
07613327616569SircaCF3893075CF 38930752023-07-14
07613327616620SircaCG3913275CG 39132752023-07-14
07613327616644SircaCG3913175CG 39131752023-07-14
07613327622706SircaCE3853075CE 38530752023-03-02
07613327169874OperonOT 1702075OT 17020752019-08-27
07613327169935OperonOT 1702175OT 17021752019-08-27
07613327169898OperonOT 1701075OT 17010752019-08-27
07613327169911OperonOT 1802075OT 18020752019-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543954zumaxZumax Medical Co., LTDKZF2026-05-21
00858480006339NOVABurton Medical, LLCKZF2026-04-02
00858480006346 NOVABurton Medical, LLCKZF2026-04-02
00858480006827 OPLEDBurton Medical, LLCKZF2026-04-02
00858480006834 AIM HIBurton Medical, LLCKZF2026-04-02
00858480006841 AIM HIBurton Medical, LLCKZF2026-04-02
00858480006858 AIM LEDBurton Medical, LLCKZF2026-04-02
00724995244286HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244309HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244330HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244347HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244378HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244293HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244354HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244361HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244385HexaLuxSTERIS CORPORATIONKZF2025-05-05
04250365155471ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155488ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155495ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155839ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155860ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365174434ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365174441ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365175530ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365189797ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
00724995225070NASTERIS CORPORATIONKZF2024-11-25
00724995225179NASTERIS CORPORATIONKZF2024-11-25
00724995225186NASTERIS CORPORATIONKZF2024-11-25
00724995225667NASTERIS CORPORATIONKZF2024-11-25
00724995225674NASTERIS CORPORATIONKZF2024-11-25