PinPoint Mouthpiece Assembly, Long

GUDID B365501530

Aktina Corp.

Stereotactic radiosurgical/radiotherapy arch head frame
Primary Device IDB365501530
NIH Device Record Key79368c5c-534c-48f5-b17d-9901c4f34a8c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePinPoint Mouthpiece Assembly, Long
Version Model Number50-153
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
HIBCCB365501530 [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 Date2021-05-31
Device Publish Date2021-05-21

Devices Manufactured by Aktina Corp.

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