CERAGEM Master V6

GUDID 08809494000082

CERAGEM Co., Ltd.

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Primary Device ID08809494000082
NIH Device Record Keyf4572ab1-71c5-4bf1-92a9-3d06548ea2bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameCERAGEM Master V6
Version Model NumberCGM MB-1701
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS108809494000082 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [CERAGEM Master V6]

08809494000099CGM MB-1702
08809494000082CGM MB-1701

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