FDA UDI
In Commercial Distribution
🇺🇸 United States
CURVED THIN OSTEOTOME BLADE 76x12 WITH HOLE
DI: 08055727372307
·
Model: 90300065840
·
HPF SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CURVED THIN OSTEOTOME BLADE 76x12 WITH HOLE
- Primary DI
- 08055727372307
- Version / Model
- 90300065840
- Company Name
- HPF SRL
- Labeler DUNS
- 895802853
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-08
- Public Version
- 1
- Public Version Date
- 2022-09-16
- Public Version Status
- New
- Public Device Record Key
- 46263799-9918-435c-a2e1-e04a5f79a146
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
- Yes
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34938 | Orthopaedic chisel blade | A device that is an interchangeable component of an orthopaedic chisel and functions as the cutting blade which is attached and locked to a dedicated handle. Together, they become a single-blade surgical instrument, bevelled on one side, intended to cut or contour bone. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design 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 | 08055727372307 | GS1 |