Circular Small Field Cone Set, Small

GUDID B365503100

The cone set is compatible with the Aktina Adapter for Elekta LINACs. Includes a set of 6 cones: 5, 7, 9, 11, 13, and 15mm.

Aktina Corp.

Fixed-aperture therapeutic x-ray system collimator
Primary Device IDB365503100
NIH Device Record Key71683e92-b3fb-40f9-a1c6-c3ee66b76dcb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCircular Small Field Cone Set, Small
Version Model Number50-310
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
GS100810110900011 [Secondary]
HIBCCB365503100 [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 Date2018-12-28
Device Publish Date2018-11-27

Devices Manufactured by Aktina Corp.

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