ROHO Single Compartment Cushion

GUDID 00613732079949

Large size configuration of a ROHO Single Compartment cushion. It may include high, mid, or low profile cells.

Roho, Inc.

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Primary Device ID00613732079949
NIH Device Record Key6fb6bee1-36e4-499d-be91-456cced910ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameROHO Single Compartment Cushion
Version Model Number1RLGHD
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
GS100613732079949 [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 Date2022-12-05
Device Publish Date2022-11-25

On-Brand Devices [ROHO Single Compartment Cushion ]

00613732079949Large size configuration of a ROHO Single Compartment cushion. It may include high, mid, or low
00613732079932Small size configuration of a ROHO Single Compartment cushion. It may include high, mid, or low
00613732053352Modified configuration of a ROHO Single Compartment Cushion. It may be any size and include hig

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