GUDID 06974757650136

GuangDong Youkey Medical Co., Ltd.

Hand-held ultrasound imaging system, body-surface
Primary Device ID06974757650136
NIH Device Record Keyba1147a1-29e3-4c30-904a-95e3d3ee408e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberP56
Company DUNS714951617
Company NameGuangDong Youkey Medical 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106974757650136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-17
Device Publish Date2023-11-09

Devices Manufactured by GuangDong Youkey Medical Co., Ltd.

06974757650075 - NA2023-11-17
06974757650082 - NA2023-11-17
06974757650099 - NA2023-11-17
06974757650105 - NA2023-11-17
06974757650112 - NA2023-11-17
06974757650129 - NA2023-11-17
06974757650136 - NA2023-11-17
06974757650136 - NA2023-11-17

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