Bolus Material 20x20x1 with film

GUDID 09120074396531

IT-V Medizintechnik GmbH

Radiological whole-body positioner
Primary Device ID09120074396531
NIH Device Record Keyedb2c775-2531-437c-9334-c43ba8838741
Commercial Distribution Discontinuation2022-02-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBolus Material 20x20x1 with film
Version Model NumberP10107-653
Company DUNS300005408
Company NameIT-V Medizintechnik 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 Batchtrue
Serial Numberfalse
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
GS109120074396531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-02-14
Device Publish Date2018-07-04

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