FDA.reportPublic FDA data

Catphan®

Primary DI
00812266030154
Brand
Catphan®
Company
Providus Holdings, Inc.
Model
CTP650-15
Catalog number
CTP650-15
Device description
38cm OD 15cm thick uniformity material body annulus
Published
2023-10-23
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
00812266030154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812266030154008122660301548122660301540812266030154

GMDN Terms#

Term, Definition table
TermDefinition
CT phantom, test objectA device that consist of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions that comes in both fixed and variable configurations. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic x-ray computed tomography (CT) imaging 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
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
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