FDA.report

HNM MEDICAL

Primary DI
00842962130278
Brand
HNM MEDICAL
Company
HNM STAINLESS, LLC.
Model
HNM-1-54-7004
Catalog number
HNM-1-54-7004
Device description
NELSON TROCAR, 35FR
Published
2023-04-17
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

Related Records

Product Codes

CodeName
FBMCannula And Trocar, Suprapubic, Non-Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
FBMCannula And Trocar, Suprapubic, Non-DisposableGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842962130278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842962130278008429621302788429621302780842962130278

GMDN Terms

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
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 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 DIBrandCompanyProduct codePublished
08403207004482Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004499Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004505Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004512Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004529Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004536Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004543Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
00842962130285HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130292HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130308HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130315HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962109052HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109069HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109076HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109083HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109090HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109106HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109113HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109021HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842962109038HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842962109045HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842331178023Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-14
00842331150944Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-12
00842331144011Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-11
00190660173449Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173456Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173463Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173470Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173487Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173494Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04