Infusion Transducer

GUDID 00888937013429

Infusion Transducer

Coopersurgical, Inc.

Urodynamic measurement system
Primary Device ID00888937013429
NIH Device Record Key9b02b7d9-02b6-43e4-aa00-8c2574ab0a68
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfusion Transducer
Version Model Number53310
Company DUNS801895244
Company NameCoopersurgical, Inc.
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 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
GS100888937013429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FENDevice, Cystometric, Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Coopersurgical, Inc.

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