Hand Grips, Elekta Compatible

GUDID B365112250

Aktina Corp.

Indexed-immobilization patient positioning system
Primary Device IDB365112250
NIH Device Record Keyff95d16c-8cd4-492f-a269-451ba4f44e52
Commercial Distribution StatusIn Commercial Distribution
Brand NameHand Grips, Elekta Compatible
Version Model Number11-225
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
HIBCCB365112250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAICouch, Radiation Therapy, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-31
Device Publish Date2021-05-21

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