FDA.reportPublic FDA data

ECTphan™

Primary DI
00812266030642
Brand
ECTphan™
Company
Providus Holdings, Inc.
Model
SMR352
Catalog number
SMR352
Device description
Line Source Plugs (Set of 3), Fillable 1mm ID clear urethane rod inset with Luer Lock fittings and end caps.
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
00812266030642PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812266030642008122660306428122660306420812266030642

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality diagnostic imaging 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. It includes phantoms that come in both fixed and variable configurations and is a quality assurance device used in both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic imaging systems. A multi-modality phantom is specifically intended for use with more than one diagnostic imaging modality, e.g., magnetic resonance imaging (MRI), ultrasound, x-ray and nuclear medicine (NM) systems.

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
00812266030659ECTphan™Providus Holdings, Inc.IXF2024-03-11
00812266030666ECTphan™Providus Holdings, Inc.IXF2024-03-11
00812266030895Magphan®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