FDA UDI
In Commercial Distribution
🇺🇸 United States
NEONAIL
DI: 07899893233335
·
Model: 931.208
·
Neoortho Produtos Ortopédicos S/A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NEONAIL
- Primary DI
- 07899893233335
- Version / Model
- 931.208
- Company Name
- Neoortho Produtos Ortopédicos S/A.
- Labeler DUNS
- 914644351
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-01
- Public Version
- 2
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- cd6ab04b-a62b-4a41-85db-fc9baf65522d
Device Description
Trochanteric Sliding Starhead Screw D10.5x110 mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66946 | Femoral neck fixation sliding bone screw | A dedicated, partially-threaded rod intended to be implanted through the sleeve of a femoral neck fixation plate/sleeve (not included) and into the neck and head of the femur to treat a trochanteric fracture. It is commonly referred to as a dynamic hip screw or lag screw, however it has no screw head, but instead includes a female thread at the proximal end to accept a compression screw. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07899893233335 | GS1 |
Customer Contacts
- Phone
- +554135351000
- [email protected]