AcuitySDR

GUDID 00810035220027

RADMEDIX, LLC

Stationary basic diagnostic x-ray system, digital
Primary Device ID00810035220027
NIH Device Record Key01ef4c89-57a1-48f4-bf68-2f43a0d7dc25
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcuitySDR
Version Model NumberPlus
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
GS100810035220027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810035220027]

Liquid Chemical


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-20
Device Publish Date2020-01-10

On-Brand Devices [AcuitySDR]

00810035220041Standard
00810035220034Standard
00810035220027Plus
00810035220010Plus
00810035220003Plus
00810035220058Plus
00810035220324Plus
00810035220317Plus

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