IMA HSG Catheters 61-5005 HSG

GUDID 00850011427217

HSG / SIS Catheters 5fr

TITUS MEDICAL LLC

Uterine injector
Primary Device ID00850011427217
NIH Device Record Key6416e170-09f8-481a-ba3a-f8fcc73d1752
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMA HSG Catheters
Version Model Number61-5005 HSG
Catalog Number61-5005 HSG
Company DUNS080306309
Company NameTITUS MEDICAL 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

Customer Support Contacts

Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com
Phone888-550-6185
Emailinfo@titusmed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850011427200 [Primary]
GS100850011427217 [Package]
Contains: 00850011427200
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKFCannula, Manipulator/Injector, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-11
Device Publish Date2024-04-03

Devices Manufactured by TITUS MEDICAL LLC

00850011427217 - IMA HSG Catheters 2024-04-11HSG / SIS Catheters 5fr
00850011427217 - IMA HSG Catheters 2024-04-11 HSG / SIS Catheters 5fr
00850011427194 - SonoInject Catheter HSG2024-04-08 SIS or HSG single Lumen Catheter 5fr
10850011427146 - HSG/SIS Trays/Kits with 5Fr catheter2021-04-05 Case of 10 HSG/SIS Trays/Kits with 5Fr catheter
10850011427153 - HSG Trays/Kits 7fr2021-04-05 Case of 10 HSG/SIS Trays/Kits with 7Fr catheter
B296063000 - 10 HSG/SIS Procedure Trays 2021-04-05 Box of 10 HSG/SIS Procedure Trays with No Catheter Included
B296063001 - 1 HSG/SIS Tray No Catheter2021-04-05 1 HSG/SIS Tray No Catheter included
B296063051 - HSG/SIS Tray/Kit with 5fr HSG Catheter 2021-04-05 1 HSG/SIS Tray/Kit with 5fr HSG Catheter
B296063071 - HSG/SIS Tray with 7fr Catheter2021-04-05 1 HSG/SIS Tray with 7fr Catheter

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