System HeelSTEP

GUDID 09120074397286

IT-V Medizintechnik GmbH

Radiological whole-body positioner
Primary Device ID09120074397286
NIH Device Record Key78c35799-0bc6-4d6b-a878-719ba8c5fb03
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystem HeelSTEP
Version Model NumberP10107-728
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 Batchfalse
Serial Numbertrue
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
GS109120074397286 [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 Date2020-08-25
Device Publish Date2020-08-17

Devices Manufactured by IT-V Medizintechnik GmbH

09120074391000 - HeadSTEP Carbon Basic Module2024-11-11
09120074391017 - HeadSTEP Carbon Flat Basic Module2024-11-11
09120074391604 - BellySTEP Baseplate2024-11-11
09120074394001 - HeadSTEP MR Basic Module2024-11-11
09120074394025 - HeadSTEP iBEAM evo Extension Basic Module2024-11-11
09120074394124 - HeadSTEP IMRT Basic Module2024-11-11
09120074394131 - HeadSTEP Shoulder Basic Module2024-11-11
09120074394148 - HS iBEAM evo Extension Push Pin2024-11-11

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