Circular Small Field Cone Insert, Elekta, 23mm

GUDID B365503022300

Aktina Corp.

Fixed-aperture therapeutic x-ray system collimator
Primary Device IDB365503022300
NIH Device Record Keyc55d0a8a-5840-4fdb-9e98-f26df8b6f885
Commercial Distribution StatusIn Commercial Distribution
Brand NameCircular Small Field Cone Insert, Elekta, 23mm
Version Model Number50-302-230
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
GS100810110900202 [Secondary]
HIBCCB365503022300 [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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