FDA.reportPublic FDA data

HNM MEDICAL

Primary DI
00842962106501
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HBI-UIC5F
Device description
UTERINE INTRODUCING CATHETER, NON BALLOON SONOHYSTEROGRAPHY CATHETER, BOX OF 25
Published
2023-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842962106501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962106501008429621065018429621065010842962106501

GMDN Terms#

Term, Definition table
TermDefinition
Suprapubic catheter introducerA rigid surgical instrument(s) intended to gain percutaneous suprapubic access via the lower abdominal wall, to the urinary bladder for placement of a drainage catheter. It includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve, and is typically made of high-grade stainless steel or durable plastic. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
806754185
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841742143672HNM MEDICALHNM-1-09-8310SHNM-1-09-8310S2025-05-16
10841742149476HNM MEDICALHNM-1-09-8308SHNM-1-09-8308S2025-05-16
10841742149483HNM MEDICALHNM-1-09-8312SHNM-1-09-8312S2025-05-16
00841742149585HNM MedicalHNM-1-57-2097HNM-1-57-20972025-04-18
00841742149592HNM MedicalHNM-1-57-2099HNM-1-57-20992025-04-18
00841742149608HNM MedicalHNM-1-57-2098HNM-1-57-20982025-04-18
10841742149353HNM MedicalHNM-45-002HNM-45-0022025-01-27
10841742149377HNM MEDICALHNM-1-62-2210SHNM-1-62-2210S2025-01-27
10841742149384HNM MEDICALHNM-1-62-2215SHNM-1-62-2215S2025-01-27
10841742149391HNM MEDICALHNM-1-62-2220SHNM-1-62-2220S2025-01-27
00841742149233HNM MedicalHNM-1-550-1524HNM-1-550-15242024-11-18
00841742148939HNM MedicalHNM-250-000-011HNM-250-000-0112024-11-08
00841742148946HNM MedicalHNM-250-000-012HNM-250-000-0122024-11-08
00841742148953HNM MedicalHNM-250-000-013HNM-250-000-0132024-11-08
00841742149219HNM MedicalHNM-250-000-014HNM-250-000-0142024-11-08
10841742149124HNM MEDICALHBI-BA-100HBI-BA-1002024-08-30
10841742148929HNM MEDICALHNM-17506HNM-175062024-05-14
00841742148854HNM MedicalHNM-250-000-001HNM-250-000-0012024-04-01
00841742148861HNM MedicalHNM-250-000-002HNM-250-000-0022024-04-01
00841742148878HNM MedicalHNM-250-000-003HNM-250-000-0032024-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20859500005008FemVueFEMASYS INC.LKF2026-01-06
30859500005005FemVueFEMASYS INC.LKF2026-01-06
00198506017919ELMED INCORPORATEDELMED INCORPORATEDLKF2025-08-11
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
00840306835889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835896Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306835902Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836022Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836046Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00840306836053Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2025-02-12
00198506074264ELMED INCORPORATEDELMED INCORPORATEDLKF2025-01-15
00198506017858ELMED INCORPORATEDELMED INCORPORATEDLKF2025-01-10
04719894432977Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432984Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894432991Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
04719894433004Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.LKF2024-12-06
00198506017827ELMED INCORPORATEDELMED INCORPORATEDLKF2024-11-14
00859500005097FemChec FEMASYS INC.LKF2024-09-16
00840306830044Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830051Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830068Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06
00840306830075Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LKF2024-08-06