ROHO QUADTRO SELECT HIGH PROFILE Cushion

GUDID 00613732112943

Roho, Inc.

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Primary Device ID00613732112943
NIH Device Record Keye145d450-4b8b-4ce2-ae51-ada91e1c7638
Commercial Distribution StatusIn Commercial Distribution
Brand NameROHO QUADTRO SELECT HIGH PROFILE Cushion
Version Model NumberQS119HD
Company DUNS006614792
Company NameRoho, 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 Datefalse
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
GS100613732112943 [Primary]

FDA Product Code

KICCushion, Flotation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-28
Device Publish Date2022-11-18

On-Brand Devices [ROHO QUADTRO SELECT HIGH PROFILE Cushion]

00613732113223QS98HD
00613732054328QS1011C
00613732054304QS1010C
00613732054281QS119C
00613732054267QS911C
00613732054243QS109C
00613732054229QS910C
00613732054205QS99C
00613732054175QS108C
00613732054168QS810C
00613732054144QS98C
00613732054120QS89C
00613732054106QS88C
00613732054083QS79C
00613732054052QS87C
00613732054045QS78C
00613732054021QS77C
00613732054007QS67C
00613732053987QS66C
00613732108236QS811C
00613732094072QS149C
00613732094065QS148C
00613732094058QS1413C
00613732094041QS1412C
00613732094034QS138C
00613732094027QS1314C
00613732094010QS128C
00613732094003QS1214C
00613732093990QS118C
00613732093983QS1114C
00613732093181QS1313C
00613732093174QS1213C
00613732093167QS1013C
00613732093150QS1113C
00613732092702QS710HD
00613732092696QS710C
00613732092689QS1312HD
00613732092672QS139HD
00613732092665QS1312C
00613732092658QS139C
00613732079901QS1110HD
00613732079437QS1411C
00613732079420QS1410C
00613732078607QS912C
00613732078584QS129C
00613732075514QS1111HD
00613732075507QS1011HD
00613732075491QS1010HD
00613732075484QS109HD
00613732075477QS911HD

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