FDA Registration
Active
🇺🇸 United States
CRW-1 System
Reg #: 1722447
·
FEI: 1000138491
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Integra Pain Management
- Registration Number
- 1722447
- FEI Number
- 1000138491
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3498 WEST 2400 SOUTH, #1050
- City
- West Valley City
- State
- UT
- ZIP
- 84119
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160811
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 |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2016-12-21 |
Proprietary Names
CRW-1 System
CRW Precision Arc Steriotactic System
CRW
Establishment Types
Repack or Relabel Medical Device