FDA Registration
Active
🇺🇸 United States
Codman Microsensor Plastic Skull Bolt Kit
Reg #: 3003418325
·
FEI: 3003418325
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Integra LifeSciences Corporation
- Registration Number
- 3003418325
- FEI Number
- 3003418325
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1100 Campus Road
- City
- Princeton
- State
- NJ
- ZIP
- 08540
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153347
Owner / Operator
- Firm Name
- Integra LifeSciences Corporation
- Operator Number
- 9004007
- Address
- 1100 Campus Rd
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2017-09-26 |
Proprietary Names
Codman Microsensor Plastic Skull Bolt Kit
Codman Microsensor Metal Skull Bolt Kit
Codman Microsensor Ventricular Catheter Kit With Tuohyborst Adapter
Codman Microsensor Basic Kit
Codman Microsensor Ventricular Catheter Kit
Establishment Types
Complaint File Establishment per 21 CFR 820.198