Universal Leveling Template, 10X10

GUDID B36511269010

Aktina Corp.

Radiation therapy beam block production plate
Primary Device IDB36511269010
NIH Device Record Key5d6f756f-1883-49a1-8b77-fcbc17710cd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Leveling Template, 10X10
Version Model Number11-269-01
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
HIBCCB36511269010 [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

On-Brand Devices [Universal Leveling Template, 10X10]

B3651126901011-269-01
B3651126804011-268-04

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