H/S Catheter

GUDID B296615007103

single unit

TITUS MEDICAL LLC

Uterine injector
Primary Device IDB296615007103
NIH Device Record Key95df94b0-38c3-4bef-a1e3-83bd24354892
Commercial Distribution StatusIn Commercial Distribution
Brand NameH/S Catheter
Version Model Number61-50071
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
HIBCCB296615007103 [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 Date2016-09-15

On-Brand Devices [H/S Catheter ]

B296615007103single unit
B29661500702box of 10 units
B296615005101single unit
B29661500500box of 10 units

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