AIOBIO

GUDID 08800043200038

AIOBIO CO.,LTD

Intraoral camera
Primary Device ID08800043200038
NIH Device Record Key5928b68a-f188-46c5-be32-e3ec341ac513
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIOBIO
Version Model NumberQraypen
Company DUNS694894136
Company NameAIOBIO 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
GS108800043200038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIAUnit, Operative Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-06
Device Publish Date2024-05-29

On-Brand Devices [AIOBIO]

08800043200199W-Block
08800043200069W-Block
08800043200038Qraypen
08800043200212LINKDENS VU

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