Low Energy Beam Block Set

GUDID B365112850

Aktina Corp.

Manual-aperture-control therapeutic x-ray system collimator, non-motorized
Primary Device IDB365112850
NIH Device Record Keyfb2eb56e-9d04-4ca7-b57d-dce7f23b7d4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLow Energy Beam Block Set
Version Model Number11-285
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
HIBCCB365112850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IXIBlock, Beam-Shaping, Radiation Therapy

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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