Small Flanel Blanket (Package of 6)

GUDID B525ST140

Octostop Inc

Radiological whole-body positioner
Primary Device IDB525ST140
NIH Device Record Key5e46af76-ffc2-48e2-99dd-5fdf9c5ef928
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmall Flanel Blanket (Package of 6)
Version Model NumberST-14
Company DUNS240536946
Company NameOctostop Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
HIBCCB525ST140 [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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