Metal Frame Table Insert, Elekta Precise

GUDID B365112050

Aktina Corp.

Radiological whole-body positioner Radiological whole-body positioner
Primary Device IDB365112050
NIH Device Record Key2d7627c2-efbf-4d01-b3df-c035028aea8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMetal Frame Table Insert, Elekta Precise
Version Model Number11-205
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
HIBCCB365112050 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-11
Device Publish Date2016-09-24

Devices Manufactured by Aktina Corp.

B36550366050 - Circular Small Field Cone Insert, Varian, 5mm2021-06-01
B36550366060 - Circular Small Field Cone Insert, Varian, 6mm2021-06-01
B36550366070 - Circular Small Field Cone Insert, Varian, 7mm2021-06-01
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
B36550366120 - Circular Small Field Cone Insert, Varian, 12mm2021-06-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.