Gel warmer

GUDID 06971355420796

SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.

Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer Gel warmer
Primary Device ID06971355420796
NIH Device Record Key8da312ba-a96c-462b-960d-552b0dc593f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameGel warmer
Version Model NumberUGW-01
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
GS106971355420796 [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 Date2021-11-08
Device Publish Date2021-10-31

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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