Ziehm Solo FD

GUDID EZIEZIEHMSOLOFD1

Ziehm Imaging GmbH

Mobile general-purpose fluoroscopic x-ray system, digital
Primary Device IDEZIEZIEHMSOLOFD1
NIH Device Record Key754983a1-cef9-49a4-bb34-f46e2853ea94
Commercial Distribution StatusIn Commercial Distribution
Brand NameZiehm Solo FD
Version Model Number132874
Company DUNS322720541
Company NameZiehm Imaging GmbH
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
HIBCCEZIEZIEHMSOLOFD1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OXOImage-Intensified Fluoroscopic X-Ray System, Mobile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-17

Devices Manufactured by Ziehm Imaging GmbH

EZIEZIEHM80001 - Ziehm 80002023-07-31 Mobile C-arm
EZIEZIEHMVISIONFD1651 - Ziehm Vision FD2023-07-31 Mobile C-arm
EZIEZIEHM8000 - Ziehm 80002020-03-20
EZIEZIEHMVISIONFD165 - Ziehm Vision FD2020-03-20
EZIEZIEHMSOLO1 - Ziehm Solo2018-07-06
EZIEZIEHMSOLOFD1 - Ziehm Solo FD2018-07-06
EZIEZIEHMSOLOFD1 - Ziehm Solo FD2018-07-06
EZIEZIEHMVISION1 - Ziehm Vision22018-07-06
EZIEZIEHMVISIONFD1 - Ziehm Vision2 FD2018-07-06

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