FDA.reportPublic FDA data

SonoInject Catheter HSG

Primary DI
00850011427194
Brand
SonoInject Catheter HSG
Company
TITUS MEDICAL LLC
Model
61-2005 HSG
Catalog number
61-2005 HSG
Device description
SIS or HSG single Lumen Catheter 5fr
Published
2024-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
00850011427194PackageGS110In Commercial Distribution
00850011427187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011427194008500114271948500114271940850011427194
00850011427187008500114271878500114271870850011427187

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

Contacts#

Phone, Email table
PhoneEmail
888-550-6185info@titusmed.com

Regulatory Flags#

DUNS number
080306309
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011427378Titus Medical LLCTM1187TM11872026-04-20
00850011427385TITUS MEDICALTM1197TM1197 WITH WIRE2026-04-19
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
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
00860011716853Monarch Medical ProductsBioteque Taiwan Ltd.LKF2026-07-24
04719894436456LTL MedicalBioteque Taiwan Ltd.LKF2026-07-24
04719894436463LTL MedicalBioteque Taiwan Ltd.LKF2026-07-24
04719894436470LTL MedicalBioteque Taiwan Ltd.LKF2026-07-24
M803003276512Uterine ManipulatorMEDGYN PRODUCTS, INC.LKF2026-06-08
M803003276515Uterine ManipulatorMEDGYN PRODUCTS, INC.LKF2026-06-08
00850011427378Titus Medical LLCTITUS MEDICAL LLCLKF2026-04-20
00850011427385TITUS MEDICALTITUS MEDICAL LLCLKF2026-04-19
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
04719894432892BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432908BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432915BiotequeBioteque Taiwan Ltd.LKF2024-12-06
04719894432922BiotequeBioteque Taiwan Ltd.LKF2024-12-06
00840306826177Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
00840306826184Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-05-08
04719894432571BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432588BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432595BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432601BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432618BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432625BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432755BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432762BiotequeBioteque Taiwan Ltd.LKF2024-04-08
04719894432779BiotequeBioteque Taiwan Ltd.LKF2024-04-08