FDA.reportPublic FDA data

Magphan®

Primary DI
00812266030895
Brand
Magphan®
Company
Providus Holdings, Inc.
Model
SMR100
Catalog number
SMR100
Device description
Magphan® 100, Complete Magphan® including 20cm spherical housing, 10cm test cube and case.
Published
2024-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IXFTest-Pattern, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXFTest-Pattern, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812266030895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812266030895008122660308958122660308950812266030895

GMDN Terms#

Term, Definition table
TermDefinition
MRI phantom, test objectA device that consists of a uniform density, or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions and material densities. It is available in both fixed and variable configurations and is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of magnetic resonance imaging (MRI) systems or magnetic resonance spectroscopy systems and associated image acquisition, display, and analysis computer programs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
104162493
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812266031403Catphan®CTP764CTP7642025-01-13
00812266030529Corgi®CGI014CGI0142024-10-03
00812266030932Rando®XA235LXA235L2024-07-11
00812266030949Rando®XA235RXA235R2024-07-11
00812266030956Rando®XA231PXA231P2024-07-11
00812266030963Rando®XA231RXA231R2024-07-11
00812266030970Rando®XA245LXA245L2024-07-11
00812266030987Rando®XA245RXA245R2024-07-11
00812266030994Rando®XA241LXA241L2024-07-11
00812266031007Rando®XA241RXA241R2024-07-11
00812266030758LiquiPhil™TLP226TLP2262024-05-07
00812266030765LiquiPhil™TLP280TLP2802024-05-07
00812266030772LiquiPhil™TLP260TLP2602024-05-07
00812266030789LiquiPhil™TLP269TLP2692024-05-07
00812266030796LiquiPhil™DDP010DDP0102024-05-07
00812266030802LiquiPhil™DDP015DDP0152024-05-07
00812266030697LiquiPhil™TLP133TLP1332024-05-03
00812266030703LiquiPhil™TLP134TLP1342024-05-03
00812266030710LiquiPhil™TLP250TLP2502024-05-03
00812266030727LiquiPhil™TLP290TLP2902024-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812266031403Catphan®Providus Holdings, Inc.IXF2025-01-13
00812266030529Corgi®Providus Holdings, Inc.IXF2024-10-03
00812266030598ECTphan™ 330Providus Holdings, Inc.IXF2024-03-11
00812266030604ECTphan™Providus Holdings, Inc.IXF2024-03-11
00812266030611ECTphan™ Providus Holdings, Inc.IXF2024-03-11
00812266030628ECTphan™Providus Holdings, Inc.IXF2024-03-11
00812266030635ECTphan™Providus Holdings, Inc.IXF2024-03-11
00812266030642ECTphan™Providus Holdings, Inc.IXF2024-03-11
00812266030659ECTphan™Providus Holdings, Inc.IXF2024-03-11
00812266030666ECTphan™Providus Holdings, Inc.IXF2024-03-11
00812266030901Magphan® Providus Holdings, Inc.IXF2024-03-11
00812266030918Magphan®Providus Holdings, Inc.IXF2024-03-11
00812266030925Magphan®Providus Holdings, Inc.IXF2024-03-11
00812266030550ATCM PhantomProvidus Holdings, Inc.IXF2024-02-09
00812266030567Low Contrast MITA Body PhantomProvidus Holdings, Inc.IXF2024-02-09
00812266030574Low Contrast MITA Head PhantomProvidus Holdings, Inc.IXF2024-02-09
00812266030581Liver PhantomProvidus Holdings, Inc.IXF2024-02-09
00812266030451Catphan®Providus Holdings, Inc.IXF2023-11-07
00812266030468Catphan®Providus Holdings, Inc.IXF2023-11-07
00812266030475Catphan®Providus Holdings, Inc.IXF2023-11-07
00812266030482Catphan®Providus Holdings, Inc.IXF2023-11-07
00812266030499Catphan®Providus Holdings, Inc.IXF2023-11-07
00812266030505Catphan®Providus Holdings, Inc.IXF2023-11-07
00812266030512Catphan®Providus Holdings, Inc.IXF2023-11-07
00812266030154Catphan®Providus Holdings, Inc.IXF2023-10-23
00812266030161Catphan®Providus Holdings, Inc.IXF2023-10-23
00812266030178Catphan®Providus Holdings, Inc.IXF2023-10-23
00812266030185Catphan®Providus Holdings, Inc.IXF2023-10-23
00812266030192Catphan®Providus Holdings, Inc.IXF2023-10-23
00812266030208Catphan®Providus Holdings, Inc.IXF2023-10-23