AcuityPDR

GUDID 00810035220171

RADMEDIX, LLC

Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital
Primary Device ID00810035220171
NIH Device Record Keya65a35e7-ea73-47a8-a4ca-c3ec56b3ed3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcuityPDR
Version Model NumberStandard
Company DUNS005057263
Company NameRADMEDIX, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS100810035220171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZLSystem, X-Ray, Mobile

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810035220171]

Liquid Chemical


[00810035220171]

Liquid Chemical


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-12
Device Publish Date2020-05-04

On-Brand Devices [AcuityPDR]

00810035220300Standard
00810035220294Standard
00810035220287Standard
00810035220270Standard
00810035220263Standard
00810035220256Standard
00810035220249Standard
00810035220232Standard
00810035220225Standard
00810035220218Standard
00810035220201Standard
00810035220195Standard
00810035220188Standard
00810035220171Standard
00810035220164Standard
00810035220157Standard
00810035220140Standard
00810035220133Standard
00810035220126Standard
00810035220119Standard
00810035220362Standard
00810035220355Standard
00810035220348Standard
00810035220331Standard

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