CT3000 Pro Base Unit

GUDID 00890477000326

SRS Medical Systems, Inc.

Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer Cystometer
Primary Device ID00890477000326
NIH Device Record Key2a00967d-7c44-4211-afad-387189f2429f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT3000 Pro Base Unit
Version Model Number900-040
Company DUNS796263598
Company NameSRS Medical Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100890477000326 [Primary]

FDA Product Code

EXQCystometer, Electrical Recording

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-07
Device Publish Date2020-09-29

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00890477000159 - Insight Discovery Algometer2021-08-30
00890477000173 - Insight Discovery PWP (w/cable)2021-08-30
00890477000180 - EMG Sensor2021-08-30

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