Laser Marker

GUDID 06971355420802

SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.

Laser patient positioning system
Primary Device ID06971355420802
NIH Device Record Keyeec8887b-9794-4704-a228-f70cd382e2aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaser Marker
Version Model NumberFU-TSDZ
Company DUNS543063066
Company NameSHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS106971355420802 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-05
Device Publish Date2021-10-28

Devices Manufactured by SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.

06971355421267 - Diagnostic Ultrasound System2023-10-19
06971355421274 - Diagnostic Ultrasound System2023-10-19
06971355421281 - Diagnostic Ultrasound System2023-10-19
06971355421298 - Diagnostic Ultrasound System2023-10-19
06971355421304 - Diagnostic Ultrasound System2023-10-19
06971355421311 - Diagnostic Ultrasound System2023-10-19
06971355421328 - Diagnostic Ultrasound System2023-10-19
06971355421335 - Diagnostic Ultrasound System2023-10-19

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