CT Overlay, GE Discovery

GUDID B365114710

Aktina Corp.

Radiological whole-body positioner
Primary Device IDB365114710
NIH Device Record Key362cc04f-7ee0-4535-a57b-bf0b2a0d93c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT Overlay, GE Discovery
Version Model Number11-471
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 Batchfalse
Serial Numbertrue
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
HIBCCB365114710 [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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B36550366060 - Circular Small Field Cone Insert, Varian, 6mm2021-06-01
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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

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