FDA UDI
In Commercial Distribution
🇺🇸 United States
NuCrani Small Plate
DI: G28433001
·
Model: 330-01
·
Neurovention LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NuCrani Small Plate
- Primary DI
- G28433001
- Version / Model
- 330-01
- Company Name
- Neurovention LLC
- Labeler DUNS
- 074912476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-21
- Public Version
- 1
- Public Version Date
- 2022-06-29
- Public Version Status
- New
- Public Device Record Key
- f62708a0-d0eb-4d80-b29c-bdde8c7329b1
Device Description
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.
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
- 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 |
|---|---|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | Neurology | 882.5320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46267 | Cranioplasty plate, alterable | An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can 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 | G28433001 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192162 | 000 |