Adapter cables unipolar/ bipolar (set of 10)

GUDID 04260441450482

CardioTek B.V.

Cardiac electrophysiology analysis system
Primary Device ID04260441450482
NIH Device Record Keyc5eb7550-142a-471e-9218-d26dfabdd0ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdapter cables unipolar/ bipolar (set of 10)
Version Model Number03UBC02
Company DUNS415868731
Company NameCardioTek B.V.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260441450482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-25
Device Publish Date2020-02-17

Devices Manufactured by CardioTek B.V.

04260441455326 - EP-TRACER2021-02-11 EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a computerized electrophysiology measurement syst
04260441455425 - EP-TRACER2020-09-22 EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system
04260441450482 - Adapter cables unipolar/ bipolar (set of 10)2020-02-25
04260441450482 - Adapter cables unipolar/ bipolar (set of 10)2020-02-25
04260441450574 - Aluminium carrying case2020-02-07
04260441455418 - EP-TRACER 2020-01-28 EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system

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