FDA.reportPublic FDA data

ACTEON

Primary DI
03760278261004
Brand
ACTEON
Company
SOPRO
Model
MINI USB2 DOCK
Catalog number
S_717_1600
Device description
Dock for dental camera
Published
2018-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NYHPlaque Disclosing Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYHPlaque Disclosing KitDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760278261004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760278261004037602782610043760278261004

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic-imaging multiformat cameraAn electrically-powered camera-based imaging unit, typically using laser scanning techniques, that is designed to capture digital images created using diagnostic imaging systems, e.g., computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), gamma camera or ultrasound, and to reproduce them in variable image formats on x-ray or radiographic film. This device usually has adjustments that allow the operator to determine how many images will be recorded on one film sheet (multi-formatting). This can be typically anywhere from 1 to 128 images in multiples of two which can be recorded onto a single sheet of film.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
264205501
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760278260434ACTEON SYSTEME PSPIX WIN MAC (Only)9970902018-11-19
03760278260939ACTEON SYSTEME PSPIX WIN MACS_702_00112018-11-19
M430S70200111ACTEON SYSTEME PSPIX WIN MACS_702_00112016-09-24
03760278267587ACTEONC50 - INTRAORAL CAMERAS_C50_00082024-05-02
03760278267594ACTEONC50 - INTRAORAL CAMERA DS_C50_00092024-05-02
03760278267020ACTEONC50 - INTRAORAL CAMERA DS_C50_00022022-09-01
03760278267037ACTEONC50 - INTRAORAL CAMERA DS_C50_00022022-09-01
03760278260045COMEG MEDICAL TECHNOLOGIESUBIPACK ENT SYSTEMSK1010162017-12-19
03760278260427COMEG MEDICALSOURCE LED SOPRO 281 BLANC (Only)9983602018-11-19
M430S21800061COMEG MEDICALSOPRO 218 - SOURCE DE LUMIERE XENON 180W - SOPRO S_218_00062016-09-24
M430S21800091COMEG MEDICALS218 SOPRO US OLYMPUSS_218_00092016-09-24
M430S21800111COMEG MEDICALS218 SOPRO US OLYMPUSS_218_00112016-09-24
M430S21800121COMEG MEDICALS218 SOPRO US WOLFS_218_00122016-09-24
M430S23000051COMEG MEDICALSOPRO 230 - SOURCE DE LUMIERE XENON 300W - SOPROS_230_00052016-09-24
M430S23000091COMEG MEDICALS230 SOPRO US OLYMPUSS_230_00092016-09-24
M430S23000111COMEG MEDICALS230 SOPRO US WOLFS_230_00112016-09-24
M430S28100011COMEG MEDICALSOURCE LED SOPRO 281 ORLS_281_00012016-09-24
M430S28100021COMEG MEDICALSOURCE LED SOPRO 281 BLANCS_281_00022016-09-24
M430S29800021COMEG MEDICALSOURCE LED SOPRO S298S_298_00022016-09-24
03760278260342COMEG MEDICAL TECHNOLOGIESPENTAX Medical LED Light SourceS_281P_01042019-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976287180831Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYH2024-07-18
00070942751469GUM®SUNSTAR AMERICAS, INC.NYH2021-08-29
03760278264906OWANDYSOPRONYH2021-01-06
03760278264913OWANDYSOPRONYH2021-01-06
03760278264920OWANDYSOPRONYH2021-01-06
02723797104727HurriViewBEUTLICH PHARMACEUTICALS, LLCNYH2019-10-01
02723797110575HurriView IIBEUTLICH PHARMACEUTICALS, LLCNYH2019-10-01
03760278261394ACTEONSOPRONYH2019-06-03
03760278261516ACTEONSOPRONYH2019-06-03
03760278260281ACTEONSOPRONYH2019-03-13
03760278261820ACTEONSOPRONYH2019-03-13
03760278262551ACTEONSOPRONYH2019-03-13
03760278262575ACTEONSOPRONYH2019-03-13
03760278262803ACTEONSOPRONYH2019-03-13
03760278260090ACTEONSOPRONYH2019-03-12
03760278260106ACTEONSOPRONYH2019-03-12
03760278260113ACTEONSOPRONYH2019-03-12
03760278260144ACTEONSOPRONYH2019-03-12
03760278260151ACTEONSOPRONYH2019-03-12
03760278260182ACTEONSOPRONYH2019-03-12
03760278260199ACTEONSOPRONYH2019-03-12
03760278260229ACTEONSOPRONYH2019-03-12
03760278261011ACTEONSOPRONYH2019-03-12
03760278261554ACTEONSOPRONYH2019-03-12
03760278261813ACTEONSOPRONYH2019-03-12
03760278261882ACTEONSOPRONYH2019-03-12
03760278261899ACTEONSOPRONYH2019-03-12
03760278261943ACTEONSOPRONYH2019-03-12
03760278261950ACTEONSOPRONYH2019-03-12
03760278261974ACTEONSOPRONYH2019-03-12