FDA Registration
Active
🇺🇸 United States
NDS SURGICAL IMAGING, LLC.
Reg #: 2954921
·
FEI: 3003301977
·
Expires 2026
Products
5
Proprietary Names
37
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- NDS SURGICAL IMAGING, LLC.
- Registration Number
- 2954921
- FEI Number
- 3003301977
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 100 Paramount Drive,, Suite 101
- City
- Sarasota
- State
- FL
- ZIP
- 34232
- Country
- US
Regulatory Submissions
- 510(k) Number
- K040443
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
- Silke - Lucht
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2008-10-31 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2010-07-12 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2008-12-05 |
| Device, Digital Image Storage, Radiological | LMB | Class 1 | Radiology | No | 2024-09-11 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2001-03-13 |
Proprietary Names
C5i
E5
C5
E3
S3c
S3
C3,
C3i
E3cHB
E3c
ZeroWire
ExpandOR
ND3, Connect OR
ScaleOR
ConductOR
E4c
ZeroWire or ZeroWire G2
RADIANCE ULTRA 32" 4K ZEROWIRE DUO
E2c
E2cHB
E2
S2c
Radiance Ultra 24" ZeroWire Embedded
Radiance Ultra Series ZeroWire Embedded
Radiance Ultra 32" ZeroWire Embedded
Radiance Ultra 55" ZeroWire Embedded
Radiance Ultra 27" ZeroWire Embedded
Evolution4K
ZeroWire Plus
ZeroWire Ultra
ND-Cam
GX5MP
Vital Screen
LifeVue
ENDOVUE
RADIANCE
Evolution family
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device