Uroflow Transducer

GUDID 00888937013412

Uroflow Transducer

Coopersurgical, Inc.

Urodynamic measurement system
Primary Device ID00888937013412
NIH Device Record Keyc16595ea-214b-4109-b186-dd083a810562
Commercial Distribution StatusIn Commercial Distribution
Brand NameUroflow Transducer
Version Model Number53309
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
GS100888937013412 [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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