Wedge Filter, Cross- Plane, Digital, 15 Degrees, S

GUDID B36556300DX150

Aktina Corp.

X-ray/radiation therapy beam filter, wedge X-ray/radiation therapy beam filter, wedge
Primary Device IDB36556300DX150
NIH Device Record Keyf59d3f8c-a569-436e-9c72-659310530b88
Commercial Distribution StatusIn Commercial Distribution
Brand NameWedge Filter, Cross- Plane, Digital, 15 Degrees, S
Version Model Number56-300-DX15
Company DUNS787178920
Company NameAktina Corp.
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
HIBCCB36556300DX150 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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