Circular Small Field Cone Insert, Elekta, 14mm

GUDID B365503021400

Aktina Corp.

Fixed-aperture therapeutic x-ray system collimator
Primary Device IDB365503021400
NIH Device Record Key88de0053-53ef-4529-895a-2d6534edae09
Commercial Distribution StatusIn Commercial Distribution
Brand NameCircular Small Field Cone Insert, Elekta, 14mm
Version Model Number50-302-140
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS100810110900110 [Secondary]
HIBCCB365503021400 [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 Date2016-10-04

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