T-DOC 5Fr Air-Charged Single Sensor Catheter

GUDID 20627825014858

T-DOC 5Fr Air-Charged Single Sensor Catheter

Laborie Medical Technologies Corp.

Urodynamic manometric catheter, electronic, single-use
Primary Device ID20627825014858
NIH Device Record Keye211e266-77ac-426c-b9b7-e079fdfd6594
Commercial Distribution StatusIn Commercial Distribution
Brand NameT-DOC 5Fr Air-Charged Single Sensor Catheter
Version Model NumberCAT595P
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
GS110627825014851 [Primary]
GS120627825014858 [Package]
Contains: 10627825014851
Package: [10 Units]
In Commercial Distribution
GS130627825014855 [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

On-Brand Devices [T-DOC 5Fr Air-Charged Single Sensor Catheter]

20627825014865T-DOC 5Fr Air-Charged Single Sensor Catheter with stylet
20627825014858T-DOC 5Fr Air-Charged Single Sensor Catheter

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