Ziehm 8000

GUDID EZIEZIEHM80001

Mobile C-arm

Ziehm Imaging GmbH

Mobile general-purpose fluoroscopic x-ray system, digital
Primary Device IDEZIEZIEHM80001
NIH Device Record Key15a4d599-3fae-46d8-a602-2d4665a5d46b
Commercial Distribution StatusIn Commercial Distribution
Brand NameZiehm 8000
Version Model Number8000
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
HIBCCEZIEZIEHM80001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-07-31
Device Publish Date2020-03-12

On-Brand Devices [Ziehm 8000]

EZIEZIEHM8000308000
EZIEZIEHM80001Mobile C-arm

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