FDA.reportPublic FDA data

NA

Primary DI
10852073002606
Brand
NA
Company
C R I
Model
HSG Tray
Catalog number
TMI1160
Device description
Includes 5F HS Catheter
Published
2016-10-10
Public version status
Update
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
K032835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032835000H/S CATHETER SETCatheter Research, Inc.2003-12-11LKF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852073002606PackageGS110In Commercial Distribution
00852073002609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085207300260610852073002606
00852073002609008520730026098520730026090852073002609

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine imaging medium catheterization kitA collection of sterile devices intended for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It includes an intrauterine imaging medium catheter, devices dedicated to catheter function (e.g., stylet, syringe), and non-dedicated supportive devices (e.g., drape, cervical dialator, gauze pad, swab sticks). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 556-0349Sales@ThomasMedical.com

Regulatory Flags#

DUNS number
130814890
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
00852073002258NALoop ElectrodeLE-04-1052016-10-07
00852073002272NALoop ElectrodeLE-05-1032016-10-07
00852073002289NALoop ElectrodeLE-06-1012016-10-10
00852073002296NALoop ElectrodeLE-06-1082016-10-10
00852073002302NALoop ElectrodeLE-07-1582016-10-07
00852073002333NALoop ElectrodeLE-09-2082016-10-10
00852073002388NALoop ElectrodeLE-12-2512016-10-10
00852073002395NABall ElectrodeLE-13-0032016-10-10
00852073002432NABall ElectrodeLE-14-0052016-10-10
00852073002463NALoop ElectrodeLE-24-2012016-10-10
00852073002364NALoop ElectrodeLE-10-2032016-10-10
00852073002371NALoop ElectrodeLE-11-2052016-10-10
10852073002361NALoop ElectrodeLE-10-2032016-10-10
10852073002378NALoop ElectrodeLE-11-2052016-10-10
00852073002319NALoop ElectrodeLE-08-1512016-10-07
00852073002487NALoop ElectrodeLE-26-1502016-10-10
10852073002316NALoop ElectrodeLE-08-1512016-10-07
10852073002484NALoop ElectrodeLE-26-1502016-10-10
00852073002814NATwo-Tap HS Catheter, 5FTMI11812016-09-30
00852073002234NALoop ElectrodeLE-01-1042016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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