Thermo Bolus 15x15x0,5cm – non perforated (5pcs)

GUDID 09120074396500

IT-V Medizintechnik GmbH

Radiological whole-body positioner
Primary Device ID09120074396500
NIH Device Record Key179a0582-6f19-4b9d-9023-20fdd2a037fe
Commercial Distribution Discontinuation2022-02-11
Commercial Distribution StatusNot in Commercial Distribution
Brand NameThermo Bolus 15x15x0,5cm – non perforated (5pcs)
Version Model NumberP10107-650
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
GS109120074396500 [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 Number7
Public Version Date2022-02-14
Device Publish Date2016-09-01

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