Patient Restraining Belt

GUDID B365561100

Aktina Corp.

Radiological whole-body positioner
Primary Device IDB365561100
NIH Device Record Key9fcd52ac-cf9d-42ee-be88-ad3e6d98d3b0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Restraining Belt
Version Model Number56-110
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
HIBCCB365561100 [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

On-Brand Devices [Patient Restraining Belt]

B36556110056-110
B36511435011-435

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