FDA UDI
In Commercial Distribution
🇺🇸 United States
HNM MEDICAL
DI: 00842962129586
·
Model: HNM-1-54-1890
·
HNM STAINLESS, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HNM MEDICAL
- Primary DI
- 00842962129586
- Version / Model
- HNM-1-54-1890
- Catalog Number
- HNM-1-62-0021
- Company Name
- HNM STAINLESS, LLC.
- Labeler DUNS
- 806754185
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-24
- Public Version
- 1
- Public Version Date
- 2023-04-03
- Public Version Status
- New
- Public Device Record Key
- bd93f36c-ba49-4555-a191-e93a6b38e8c5
Device Description
LEBSCHE STERNUM KNIFE, 10", 1 1/4"X9 3/4" BLADES
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 |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35143 | Sternum knife | A heavy-duty, hand-held manual surgical instrument designed for cutting into the sternum (the breastbone). It typically has a T-shaped handle to allow the application of pressure to the blade which descends from the handle in a thick shaft terminating in various contours. It is typically made of high-grade stainless steel; its handle may be made of a synthetic polymer (e.g., Tufnol). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842962129586 | GS1 |