FDA.reportPublic FDA data

SUPER ULSTAR

Primary DI
08809178550162
Brand
SUPER ULSTAR
Company
Durico C&T Inc.
Model
SUPER ULSTAR-840S
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809178550169PackageGS110In Commercial Distribution
28809178550166PackageGS110In Commercial Distribution
08809178550162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880917855016918809178550169
2880917855016628809178550166
08809178550162088091785501628809178550162

GMDN Terms#

Term, Definition table
TermDefinition
Medical printer paperA thin sheet of fibrous material intended to be used to produce a hard copy of printed data/images generated by a medical device (e.g., laboratory instrument/analyser, electrocardiograph, x-ray imaging system, hospital printer). It is typically available as a continuous length of paper (e.g., roll or accordion) or as individual sheets of paper; some types are pre-treated with thermochromic ink for use with thermal printers. This is a single-use device.

Regulatory Flags#

DUNS number
687570502
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809178550117SUPER ULSTARSUPER ULSTAR-1100S2022-12-09
08809178550124SUPER ULSTARSUPER ULSTAR-1100HD2022-12-09
08809178550131SUPER ULSTARSUPER ULSTAR-2100HD2022-12-09
08809178550148SUPER ULSTARSUPER ULSTAR-1100HD Matt2022-12-09
08809178550155SUPER ULSTARSUPER ULSTAR-840HG2022-12-09
08809178550339SUPER ULSTARSUPER ULSTAR-1100HD Mibi2022-12-09
08809178550346SUPER ULSTARSUPER ULSTAR-1100S Mibi2022-12-09
08809178550100SUPER ULSTARSUPER ULSTAR-1100HG2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810111225663X-ray AppTreace Medical Concepts, Inc.LMD2026-05-01
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
05415334057258Eonis 32”Barco NVLMD2026-04-13
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-02-27
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
00850025268394Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-01-21
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00850013331086SentiARSentiar, Inc.LMD2025-11-21
00850013331093SentiARSentiar, Inc.LMD2025-11-21
00850013331109SentiARSentiar, Inc.LMD2025-11-21
00850061871374IMAGE DIAGNOSTICS INCIMAGE DIAGNOSTICS, INC.LMD2025-11-18
00850054590145interWORKSAvreo IncLMD2025-11-14
00850025268387Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-11-03
00850025268370Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2025-09-24
00857534006868IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
00857534006875IMRISmatrix 5.0IMRIS Imaging, Inc.LMD2025-09-18
03770024341072Sonio Pro v3SONIOLMD2025-08-28
00850054590138interWORKSAvreo IncLMD2025-08-26
00628105001199Vitrea ReadCanon Medical Informatics A/SLMD2025-08-15
00818834028837MiiS Horus Endoscope Display System -Video BoxTRI-ANIM HEALTH SERVICES, INC.LMD2025-08-12
08800184000009I-Rapha ViewIRM IncLMD2025-08-01