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
System, Image Processing, Radiological LLZ
Laparoscope, General & Plastic Surgery GCJ
System, Digital Image Communications, Radiological LMD
Device, Digital Image Storage, Radiological LMB
Camera, Surgical And Accessories KQM

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