RadPRO OMNERA 400A

GUDID 07350008750012

Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended fo

Arcoma AB

Stationary basic diagnostic x-ray system, digital
Primary Device ID07350008750012
NIH Device Record Key0d310730-f567-4b4e-8dde-a3e1bfb9fd55
Commercial Distribution StatusIn Commercial Distribution
Brand NameRadPRO OMNERA 400A
Version Model Number0072
Company DUNS356774109
Company NameArcoma AB
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se
Phone+46(0)470706970
Emailservice@arcoma.se

Device Identifiers

Device Issuing AgencyDevice ID
GS107350008750012 [Primary]

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-12-04

Devices Manufactured by Arcoma AB

07350008750098 - OMNERA 500A2022-04-07 Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The dev
07350008750012 - RadPRO OMNERA 400A2018-03-29Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended fo
07350008750012 - RadPRO OMNERA 400A2018-03-29 Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The dev
07350008750050 - RadPRO OMNERA 400T2018-03-29 Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environme

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