ROHO 1RDS Cushion

GUDID 00613732074180

Roho, Inc.

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Primary Device ID00613732074180
NIH Device Record Keyb57b8254-9c2a-40a8-b317-5bb689f03bba
Commercial Distribution StatusIn Commercial Distribution
Brand NameROHO 1RDS Cushion
Version Model Number1RDS1818C
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
GS100613732074180 [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 1RDS Cushion ]

006137320741971RDS2018C
006137320741801RDS1818C
006137320741731RDS1816C
006137320741661RDS1618C
006137320741591RDS1616C

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