FDA.report

SCALEOR

Primary DI
04961333244331
Brand
SCALEOR
Company
PENTAX OF AMERICA, INC.
Model
SCALE OR
Device description
SCALEOR, DVI INPUT, W/OUT FIBER
Published
2018-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04961333244331PrimaryGS10

GMDN Terms

TermDefinition
Endoscopic video image display monitorA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a flexible video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.

Sterilization Methods

Method

Regulatory Flags

DUNS number
083211284
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04961333244355BRANDMAXU-5LH2018-03-15
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