R2 STUDIO Q RCT820

GUDID 08809708752622

Megagen Implant Co. Ltd

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device ID08809708752622
NIH Device Record Keyd1d26e35-b6e2-4a78-9294-5889137b3566
Commercial Distribution StatusIn Commercial Distribution
Brand NameR2 STUDIO Q
Version Model NumberRCT820
Catalog NumberRCT820
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809708752622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

Liquid Chemical


[08809708752622]

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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