FDA Registration
Active
🇺🇸 United States
ZeroWire
Reg #: 2954921
·
FEI: 3003301977
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- NDS SURGICAL IMAGING, LLC.
- Registration Number
- 2954921
- FEI Number
- 3003301977
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 100 Paramount Drive,, Suite 101
- City
- Sarasota
- State
- FL
- ZIP
- 34232
- Country
- US
Regulatory Submissions
- 510(k) Number
- K100195
Owner / Operator
- Firm Name
- NDS Surgical Imaging, LLC
- Operator Number
- 9045073
- Address
- Salzufer 8
- City
- Berlin
- State
- DE-BE
- Postal Code
- 10587
- Country
- DE
- Correspondent
- Sofia - Panagou
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2010-07-12 |
Proprietary Names
ZeroWire
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device