ECTphan™ SMR341

GUDID 00812266030611

Fillable low-contrast insert rod with 20mm, 15mm, and 10mm ID

Providus Holdings, Inc.

Multi-modality diagnostic imaging phantom, test object
Primary Device ID00812266030611
NIH Device Record Keybd304477-d6c7-4b57-b65a-10a74029d8b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameECTphan™
Version Model NumberSMR341
Catalog NumberSMR341
Company DUNS104162493
Company NameProvidus Holdings, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812266030611 [Primary]

FDA Product Code

IXFTest-Pattern, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-19
Device Publish Date2024-03-11

On-Brand Devices [ECTphan™ ]

00812266030666ECT Point Source Phantom, cylindrical, liquid filled tank with 3 point sources for performing MT
008122660306593D Image Fusion Ramp Cube, The 3D Image Fusion Ramp Cube enables verification of registration fo
00812266030642Line Source Plugs (Set of 3), Fillable 1mm ID clear urethane rod inset with Luer Lock fittings a
00812266030635ECTphan™ Line Source Phantom, 20cm tank with 3 SMR352, line sources, and cantilever case mount
00812266030628Solid "cold" low contrast rod with 20mm, 15mm, and 10mm ODs
00812266030611Fillable low-contrast insert rod with 20mm, 15mm, and 10mm ID
00812266030604ECTphan™ 330SR, Complete ECTphan™ including uniformity inserts and cantilever case mounting

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