FDA UDI
In Commercial Distribution
🇺🇸 United States
Neuro Plating System
DI: 08809416061689
·
Model: NSQ304X04A
·
OSTEONIC CO.,Ltd.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Neuro Plating System
- Primary DI
- 08809416061689
- Version / Model
- NSQ304X04A
- Company Name
- OSTEONIC CO.,Ltd.
- Labeler DUNS
- 688999370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-13
- Public Version
- 3
- Public Version Date
- 2020-02-05
- Public Version Status
- Update
- Public Device Record Key
- 7022397d-0c38-4420-a303-30728c78e7a8
Device Description
Square Plate, Extra Long, 4Hole
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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| HBW | Fastener, Plate, Cranioplasty | Neurology | 882.5360 | 2 |
| GXR | Cover, Burr Hole | Neurology | 882.5250 | 2 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | Neurology | 882.5320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46268 | Cranioplasty plate, non-alterable | An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809416061689 | GS1 |