FDA.reportPublic FDA data

TITUS MEDICAL

Primary DI
00850011427385
Brand
TITUS MEDICAL
Company
TITUS MEDICAL LLC
Model
TM1197
Catalog number
TM1197 WITH WIRE
Device description
HSG CATHETER 7FR WITH GUIDE WIRE 3cc Balloon
Published
2026-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LKFCannula, Manipulator/Injector, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKFCannula, Manipulator/Injector, UterineObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092969000H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007FSterling Medical, Inc.2010-04-30LKF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011427385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011427385008500114273858500114273850850011427385

GMDN Terms#

Term, Definition table
TermDefinition
Uterine injectorA hand-held manual device designed to inject/administer liquids into the uterus and/or fallopian tubes, typically contrast medium during radiographic procedures to evaluate tubal patency. It is typically used in conjunction with an appropriate intrauterine catheter which may be manipulated through an external mechanism. The injector may be used to manipulate or reposition the uterus during diagnostic and/or surgical procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
080306309
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011427378Titus Medical LLCTM1187TM11872026-04-20
00850011427200IMA HSG Catheters 61-5005 HSG61-5005 HSG2024-04-03
00850011427217IMA HSG Catheters 61-5005 HSG61-5005 HSG2024-04-03
00850011427187SonoInject Catheter HSG61-2005 HSG61-2005 HSG2024-03-31
00850011427194SonoInject Catheter HSG61-2005 HSG61-2005 HSG2024-03-31
B29606107X0Sonocath06-107X2017-01-20
B29606107X10Sonocath06-107X12017-01-20
B29606105X0Sonocath06-105X2017-01-20
B29606105X10Sonocath06-105X12017-01-20
B296C070709HSG CatheterC07072016-09-15
10850011427146HSG/SIS Trays/Kits with 5Fr catheter06-3052021-03-27
10850011427153HSG Trays/Kits 7fr06-3072021-03-27
B29606300010 HSG/SIS Procedure Trays 06-30006-3002021-03-27
B2960630011 HSG/SIS Tray No Catheter06-300 2021-03-27
B296063051HSG/SIS Tray/Kit with 5fr HSG Catheter 06-3052021-03-27
B296063071HSG/SIS Tray with 7fr Catheter06-3072021-03-27
B29606105X400Sonocath06-105X402017-01-20
B296063050HSG Trays 06-3052016-09-16
B296063070HSG Trays 06-3072016-09-16
B296B0500FIRM0HSG CatheterB0500-FIRM2016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011427378Titus Medical LLCTITUS MEDICAL LLCLKF2026-04-20
20859500005008FemVueFEMASYS INC.LKF2026-01-06
30859500005005FemVueFEMASYS INC.LKF2026-01-06
00888937029697ALLY II UPS (Uterine Positioning System)Coopersurgical, Inc.LKF2025-12-18
00198506017919ELMED INCORPORATEDELMED INCORPORATEDLKF2025-08-11
00198506017704ELMED INCORPORATEDELMED INCORPORATEDLKF2025-07-08
00860010540930Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
10860010540937Rejoni Ribbed CatheterRejoni, Inc.LKF2025-02-18
00840306835360Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835377Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835384Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835391Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835407Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835544Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
04719894432892Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432908Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432915Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432922Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
00840306826177Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
00840306826184Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
04719894432571Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-04-08
04719894432588Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-04-08
04719894432595Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-04-08
04719894432601Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-04-08
04719894432618Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-04-08
04719894432625Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-04-08
04719894432755Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-04-08
04719894432762Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-04-08