JENITEK

GUDID 06973102450018

Suzhou Jenitek Precision Device Co., Ltd.

Cardiac pulse generator test magnet
Primary Device ID06973102450018
NIH Device Record Keye661a362-451b-4b6c-b85d-0dd315dd72a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameJENITEK
Version Model NumberPacemaker test magnet 50311000
Company DUNS542975488
Company NameSuzhou Jenitek Precision Device Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106973102450018 [Primary]
GS116973102450015 [Package]
Package: Outer package [20 Units]
In Commercial Distribution

FDA Product Code

DTGMagnet, Test, Pacemaker

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-14
Device Publish Date2020-07-06

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