HSG Catheter

GUDID B296E0500FIRM0

single unit

TITUS MEDICAL LLC

Uterine injector
Primary Device IDB296E0500FIRM0
NIH Device Record Keyfe3b1461-c3f2-4bf4-b40d-d401cf473f52
Commercial Distribution StatusIn Commercial Distribution
Brand NameHSG Catheter
Version Model NumberE0500-FIRM
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB296E0500FIRM0 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

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B296E0700FR03single unit
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B296C070709Case of 40 Units
B296C0700FR01Case of 40 Units
B296C0700FIRM0Case of 40 Units
B296C050505Case of 40 Units
B296C0500FR0Case of 40 Units
B296C0500FIRM0Case of 40 Units
B296B070708box of 10 units
B296B0700FR00box of 10 units
B296B0700FIRM0box of 10 units
B296B05050box of 10 units
B296B0500FR0box of 10 units
B296B0500FIRM0box of 10 units
B29606107F400Case of 40 Units
B29606107F10single unit
B29606107F0box of 10 units
B296061070Case of 100 Units Bulk
B29606105F400Case of 40 Units
B29606105F10single unit
B29606105F0box of 10 units
B296061050Case of 100 Units Bulk
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