Sonsotik Single Port Catheter

GUDID 00840155409835

Single Port ClearSafe, Closed Catheter 16G x 1.25”

MEDSOURCE INTERNATIONAL LLC

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Primary Device ID00840155409835
NIH Device Record Keyd32830d2-4e03-4653-8cd6-9edf54ae5199
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonsotik Single Port Catheter
Version Model NumberMS-87116
Company DUNS041674552
Company NameMEDSOURCE INTERNATIONAL LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840155409811 [Primary]
GS100840155409835 [Package]
Contains: 00840155409811
Package: Box [50 Units]
In Commercial Distribution
GS100840155409859 [Package]
Contains: 00840155409811
Package: Case [200 Units]
In Commercial Distribution

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-27
Device Publish Date2021-09-17

On-Brand Devices [Sonsotik Single Port Catheter]

00840155409965Single Port ClearSafe, Closed Catheter 24G x 0.75”
00840155409934Single Port ClearSafe, Closed Catheter 22G x 1”
00840155409903Single Port ClearSafe, Closed Catheter 20G x 1.25”
00840155409873Single Port ClearSafe, Closed Catheter 18G x 1.25”
00840155409835Single Port ClearSafe, Closed Catheter 16G x 1.25”
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