BOUNDER Plus

GUDID 00861980000493

21ST CENTURY SCIENTIFIC, INC.

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Primary Device ID00861980000493
NIH Device Record Key5c5cdc65-6668-41a2-b284-dd1d5b916e24
Commercial Distribution StatusIn Commercial Distribution
Brand NameBOUNDER Plus
Version Model NumberPower Gurney
Company DUNS099447922
Company Name21ST CENTURY SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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
GS100861980000493 [Primary]

FDA Product Code

INKStretcher, Wheeled, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-20
Device Publish Date2023-06-12

On-Brand Devices [BOUNDER Plus]

00861980000486Manual Gurney
00861980000493Power Gurney

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