CERAGEM Master V3

GUDID 08809494000006

CERAGEM Co., Ltd.

Large-area electric massager
Primary Device ID08809494000006
NIH Device Record Key9cd89808-8d3c-47c2-a98e-b4fd261d0144
Commercial Distribution StatusIn Commercial Distribution
Brand NameCERAGEM Master V3
Version Model NumberCGM MB-1101
Company DUNS688326136
Company NameCERAGEM Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS108809494000006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JFBTable, Physical Therapy, Multi Function

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-08-20
Device Publish Date2016-07-29

Devices Manufactured by CERAGEM Co., Ltd.

08809494000082 - CERAGEM Master V62021-04-08
08809494000099 - CERAGEM Master V62021-04-08
08809494000075 - CERAGEM Master V42021-03-22
08809494000006 - CERAGEM Master V32020-08-20
08809494000006 - CERAGEM Master V32020-08-20

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