Triple Lumen Catheter 9F Male

GUDID 10627825000304

Laborie Medical Technologies Canada ULC

Urodynamic manometric catheter, non-electronic Urodynamic manometric catheter, non-electronic
Primary Device ID10627825000304
NIH Device Record Keya22ed243-979b-484d-95cb-fb803e5c6750
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriple Lumen Catheter 9F Male
Version Model NumberTLC-9M
Company DUNS203383526
Company NameLaborie Medical Technologies Canada ULC
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100627825000307 [Primary]
GS110627825000304 [Package]
Contains: 00627825000307
Package: [10 Units]
In Commercial Distribution
GS120627825000301 [Package]
Package: [240 Units]
In Commercial Distribution

FDA Product Code

FENDEVICE, CYSTOMETRIC, HYDRAULIC

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10627825000304]

Ethylene Oxide


[10627825000304]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-21

Devices Manufactured by Laborie Medical Technologies Canada ULC

30627825007024 - Extension Set 22022-07-04
20627825007294 - Extension Line, 60 cm2022-07-04
20627825007317 - Extension Line, 1500mm2022-07-04
20627825007324 - Extension Line, 15cm2022-07-04
20627825007348 - Extension Line, 150cm Blue2022-07-04
30627825007352 - Extension Line, 150cm Yellow2022-07-04
20627825007034 - Extension Set 32022-07-04
30627825007307 - Extension Line, 90 cm2022-07-04

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