R2 STUDIO Q RCT820-SC

GUDID 08809708755005

Megagen Implant Co. Ltd

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device ID08809708755005
NIH Device Record Key0b03fd78-a587-4613-a939-3fd5226f21ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameR2 STUDIO Q
Version Model NumberRCT820-SC
Catalog NumberRCT820-SC
Company DUNS687388178
Company NameMegagen Implant 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
GS108809708755005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


[08809708755005]

Liquid Chemical


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-30
Device Publish Date2023-11-22

On-Brand Devices [R2 STUDIO Q]

08809708755005RCT820-SC
08809708752622RCT820

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