Universal Leveling Template, 25X25

GUDID B36511268010

Aktina Corp.

Radiation therapy beam block production plate Radiation therapy beam block production plate
Primary Device IDB36511268010
NIH Device Record Key97373667-6427-4602-89da-b2b8df65072b
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Leveling Template, 25X25
Version Model Number11-268-01
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
HIBCCB36511268010 [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 Date2016-09-27

Devices Manufactured by Aktina Corp.

B3658080000 - isoPoint Validation Software2024-07-09 Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz t
B36550366050 - Circular Small Field Cone Insert, Varian, 5mm2021-06-01
B36550366060 - Circular Small Field Cone Insert, Varian, 6mm2021-06-01
B36550366070 - Circular Small Field Cone Insert, Varian, 7mm2021-06-01
B36550366080 - Circular Small Field Cone Insert, Varian, 8mm2021-06-01
B36550366090 - Circular Small Field Cone Insert, Varian, 9mm2021-06-01
B36550366100 - Circular Small Field Cone Insert, Varian, 10mm2021-06-01
B36550366110 - Circular Small Field Cone Insert, Varian, 11mm2021-06-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.