FDA.reportPublic FDA data

Rejoni Ribbed Catheter

Primary DI
10860010540937
Brand
Rejoni Ribbed Catheter
Company
Rejoni, Inc.
Model
RC-2015
Catalog number
RC-2015
Device description
The Rejoni Intrauterine Catheter is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Rejoni Intrauterine Catheter can be used for evaluation of tubal patency. The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).
Published
2025-02-18
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
K222798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222798000Rejoni Intrauterine CatheterRejoni, Inc.2022-12-16LKF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010540930PrimaryGS10
10860010540937Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010540930008600105409308600105409300860010540930
1086001054093710860010540937

GMDN Terms#

Term, Definition table
TermDefinition
Hysterosonography/endometrial biopsy catheterA flexible tube designed for combined saline infusion sonohysterography (SIS) and biopsy functionality providing the physician with increased visibility offered by a sonohysterography during a diagnostic image ultrasound and the ability to take a biopsy of endometrial tissue during the same gynaecological procedure. It is introduced via the vagina and allows the uterus to be filled with saline which is retained with an acorn-tipped stopper placed against the cervical opening; a biopsy can be taken if indicated. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118420242
Device count
5
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010540930Rejoni Ribbed CatheterRC-2015RC-20152025-02-18
00860010540909Rejoni Intrauterine CatheterCA-2015CA-20152023-07-14

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
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