WingSTEP low for Varian Baseplate

GUDID 09120074395329

IT-V Medizintechnik GmbH

Radiological chest positioner
Primary Device ID09120074395329
NIH Device Record Key1c810802-5f54-4e0d-b9df-fff246266e00
Commercial Distribution StatusIn Commercial Distribution
Brand NameWingSTEP low for Varian Baseplate
Version Model NumberP10107-532
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109120074395329 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-20
Device Publish Date2024-11-12

Devices Manufactured by IT-V Medizintechnik GmbH

09120074394018 - HeadSTEP IMRT MR Basic Module2024-11-20
09120074395312 - WingSTEP high for Varian Baseplate2024-11-20
09120074395329 - WingSTEP low for Varian Baseplate2024-11-20
09120074395329 - WingSTEP low for Varian Baseplate2024-11-20
09120074395404 - BreastSTEP Short Mask Basic Module2024-11-20
09120074395411 - BreastSTEP Long Mask Basic Module2024-11-20
09120074395428 - BreastSTEP Short MR Basic Module2024-11-20
09120074395435 - BreastSTEP Long MR Basic Module2024-11-20
09120074391000 - HeadSTEP Carbon Basic Module2024-11-11

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