SondeAR - Air Charged Catheter

GUDID 10627825008225

Laborie Medical Technologies Canada ULC

Urodynamic manometric catheter, non-electronic
Primary Device ID10627825008225
NIH Device Record Key114224b5-af71-481e-a1bc-1523b4028f84
Commercial Distribution StatusIn Commercial Distribution
Brand NameSondeAR - Air Charged Catheter
Version Model NumberSAR-AC
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
GS100627825008228 [Primary]
GS110627825008225 [Package]
Contains: 00627825008228
Package: [10 Units]
In Commercial Distribution

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

On-Brand Devices [SondeAR - Air Charged Catheter]

10627825008249SAR-PC
10627825008232SAR-AL
10627825008225SAR-AC

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