Leg Support Coxafix Stirrup, Pair, Siemens Compatible

GUDID B365560530

Aktina Corp.

Indexed-immobilization patient positioning system
Primary Device IDB365560530
NIH Device Record Key9cd4116f-f5d2-4230-927b-4a48a641abd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeg Support Coxafix Stirrup, Pair, Siemens Compatible
Version Model Number56-053
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
HIBCCB365560530 [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.

B3658080000 - isoPoint Validation Software2024-07-09 Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz t
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

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