OMNERA 500A

GUDID 07350008750098

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

Arcoma AB

Stationary basic diagnostic x-ray system, digital
Primary Device ID07350008750098
NIH Device Record Key2f0c33db-867d-415d-982f-03874cc50e4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameOMNERA 500A
Version Model NumberPrecision i5
Company DUNS356774109
Company NameArcoma AB
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

Customer Support Contacts

Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se
Phone+46470706900
Emailservice@arcoma.se

Device Identifiers

Device Issuing AgencyDevice ID
GS107350008750098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-07
Device Publish Date2022-03-30

Devices Manufactured by Arcoma AB

07350008750098 - OMNERA 500A2022-04-07Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
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 400A2018-03-29 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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