FDA.reportPublic FDA data

Monarch Medical Products

Primary DI
00860011716853
Brand
Monarch Medical Products
Company
Bioteque Taiwan Ltd.
Model
MM1150A
Published
2026-07-24
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

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
K102898000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102898000BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONEPanpac Medical Corporation2011-12-15LKF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011716815PackageGS125In Commercial Distribution
00860011716853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011716815008600117168158600117168150860011716815
00860011716853008600117168538600117168530860011716853

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine imaging medium catheterA flexible tube designed 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 is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device.

Regulatory Flags#

DUNS number
657769858
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011927617Monarch Medical ProductsMM012502026-07-24
00860011927662Monarch Medical ProductsMM00152026-07-24
00860011927686Monarch Medical ProductsMM010252026-07-24
04719894435893LTL MedicalCUd12026-07-24
04719894435909LTL MedicalCUd22026-07-24
04719894435916LTL MedicalCUd32026-07-24
04719894435923LTL MedicalCUd42026-07-24
04719894435930LTL MedicalCUd52026-07-24
04719894435947LTL MedicalCUd62026-07-24
04719894435954LTL MedicalCUd72026-07-24
04719894435961LTL MedicalD12026-07-24
04719894435978LTL MedicalD22026-07-24
04719894435985LTL MedicalD32026-07-24
04719894435992LTL MedicalD42026-07-24
04719894436005LTL MedicalD52026-07-24
04719894436012LTL MedicalD62026-07-24
04719894436029LTL MedicalDSHs12026-07-24
04719894436036LTL MedicalDSHs22026-07-24
04719894436043LTL MedicalDSHs32026-07-24
04719894436050LTL MedicalDSHs42026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840306835360Marina 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