Universal Leveling Template, 20X20

GUDID B36511268020

Aktina Corp.

Radiation therapy beam block production plate
Primary Device IDB36511268020
NIH Device Record Key1e0ef6f2-58be-4f5f-b987-81c21b5449d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Leveling Template, 20X20
Version Model Number11-268-02
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
HIBCCB36511268020 [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

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