Mesh Insert Side Opening, Short Version

GUDID B365112180

Aktina Corp.

Radiological whole-body positioner
Primary Device IDB365112180
NIH Device Record Keye702fbdb-d6e2-4ab8-8e23-fe3b474c4c30
Commercial Distribution StatusIn Commercial Distribution
Brand NameMesh Insert Side Opening, Short Version
Version Model Number11-218
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
HIBCCB365112180 [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

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