T-DOC 5Fr Air-Charged Abdominal Sensor Catheter

GUDID 20627825014841

T-DOC 5Fr Air-Charged Abdominal Sensor Catheter

Laborie Medical Technologies Corp.

Urodynamic manometric catheter, electronic, single-use
Primary Device ID20627825014841
NIH Device Record Keya3087454-bbc2-416f-8e87-a4771ef72053
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-DOC 5Fr Air-Charged Abdominal Sensor Catheter
Version Model NumberCAT575
Company DUNS117783313
Company NameLaborie Medical Technologies Corp.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110627825014844 [Primary]
GS120627825014841 [Package]
Contains: 10627825014844
Package: [10 Units]
In Commercial Distribution
GS130627825014848 [Package]
Package: [100 Units]
In Commercial Distribution

FDA Product Code

FENDevice, Cystometric, Hydraulic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-20
Device Publish Date2024-12-12

Devices Manufactured by Laborie Medical Technologies Corp.

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20627825014841 - T-DOC 5Fr Air-Charged Abdominal Sensor Catheter2024-12-20T-DOC 5Fr Air-Charged Abdominal Sensor Catheter
20627825014841 - T-DOC 5Fr Air-Charged Abdominal Sensor Catheter2024-12-20 T-DOC 5Fr Air-Charged Abdominal Sensor Catheter
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20627825014865 - T-DOC 5Fr Air-Charged Single Sensor Catheter2024-12-20 T-DOC 5Fr Air-Charged Single Sensor Catheter with stylet

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