FDA.report

DRYPRO SIGMA 2

Primary DI
04560141945630
Brand
DRYPRO SIGMA 2
Company
KONICA MINOLTA, INC.
Model
A9R4
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LMCCamera, Multi Format, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LMCCamera, Multi Format, RadiologicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560141945630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560141945630045601419456304560141945630

GMDN Terms

TermDefinition
Diagnostic-imaging multiformat cameraA mains electricity (AC-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

Regulatory Flags

DUNS number
692076161
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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60889976559352DRYVIEW 5700 Laser Imaging SystemCARESTREAM HEALTH, INC.LMC2017-04-28
04560141932487DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
04560141932494DRYPRO SIGMAKONICA MINOLTA, INC.LMC2016-10-05
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