FDA.reportPublic FDA data

Foot Pedal

Primary DI
07290017025063
Brand
Foot Pedal
Company
ORPHEUS MEDICAL LTD
Model
01
Catalog number
MPU-EG00C01
Device description
" A ""2 part"" medical Foot Pedal connected to the Orpheus CAST to operate: start/stop, snapshot taking."
Published
2017-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017025063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017025063072900170250637290017025063

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533221750
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
07290017025056Orpheus Switch01MVU-EG00D012017-06-05
07290017025124Orpheus CAST Mobile App Android OS01ML-EG300012020-04-14
72900170251011Orpheus CAST Mobile App + Andriod01MLL-EG300012017-06-05
07290017025100Orpheus CAST Mobile App iOS + Android01MLL-EG300012019-09-03
07290017025001Orpheus System01MVD-00012017-06-05
07290017025018Orpheus CAST 22 inch01MCU-EG004012017-06-05
07290017025025Orpheus CAST 24 inch HD Unit01MCU-EG004022017-06-05
07290017025032Orpheus CAST 15 inch01MCU-EG004072017-06-05
07290017025049Orpheus CAST w/o Display OD Unit01MCU-EG004082017-06-05
07290017025070Bar Code Reader01MCU-EG004052017-06-05
07290017025087Central Archive module 01MAU-EG200012017-06-05
07290017025094Orpheus CAST App01MAU-EG200042017-06-05
07290017025101Orpheus CAST Mobile App + Andriod01MLL-EG300012017-06-05
07290017025117Orpheus VOD CSS01MSU-EG300012017-06-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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