Octoroll

GUDID B525UM020

Octostop Inc

Radiological whole-body positioner
Primary Device IDB525UM020
NIH Device Record Key832eab90-619b-4acd-952a-d8354c4b9bc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameOctoroll
Version Model NumberUM-02
Company DUNS240536946
Company NameOctostop Inc
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB525UM020 [Primary]

FDA Product Code

KXHCradle, patient, radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-03-11
Device Publish Date2017-11-16

Devices Manufactured by Octostop Inc

B525BO020 - Standard Board2019-03-11
B525BO030 - Large Board2019-03-11
B525CO010 - Large U Head Cushions2019-03-11
B525CO020 - Small U Head Cushions2019-03-11
B525CO030 - L Head and Arm Cushions2019-03-11
B525OC010 - Octogones2019-03-11
B525OC020 - Vertical Support2019-03-11
B525PA030 - Octopaque no Accessories2019-03-11

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