FDA UDI
In Commercial Distribution
🇺🇸 United States
HNM MEDICAL
DI: 00842962130278
·
Model: HNM-1-54-7004
·
HNM STAINLESS, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HNM MEDICAL
- Primary DI
- 00842962130278
- Version / Model
- HNM-1-54-7004
- Catalog Number
- HNM-1-54-7004
- Company Name
- HNM STAINLESS, LLC.
- Labeler DUNS
- 806754185
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-17
- Public Version
- 2
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- cfd16f29-3448-486c-b551-5b3a9790604b
Device Description
NELSON TROCAR, 35FR
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FBM | Cannula And Trocar, Suprapubic, Non-Disposable | Gastroenterology, Urology | 876.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32021 | Suprapubic catheter introducer, reusable | A rigid surgical instrument(s) intended to gain percutaneous suprapubic access to the urinary bladder, via the lower abdominal wall, for placement of a drainage catheter (not included). It includes a sharp pointed trocar blade and/or a suprapubic access cannula/sleeve, and is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842962130278 | GS1 |