FDA Registration
Active
🇺🇸 United States
IDSS-SLC (version 7 and 8) (RM-CFE)
Reg #: 3008776287
·
FEI: 3008776287
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Black Diamond Video, Inc.
- Registration Number
- 3008776287
- FEI Number
- 3008776287
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 503 Canal Blvd
- City
- Richmond
- State
- CA
- ZIP
- 94804
- Country
- US
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10078069
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2020-10-09 |
Proprietary Names
IDSS-SLC (version 7 and 8) (RM-CFE)
Free 5 Camera System (RM-MF)
Vividimage T HD Surgical Display (RM-CFE)
VividImage W 4K 65 4K Medical Wall Display (RM-RR)
Vividimage W HD Wall Display 65-inch (RM-RR)
VividImage 31" 4K Surgical Monitor (RM-RR)
HexaVue Integration System - Camera Control (RM-MF)
HexaVue IP In-Light Camera Control System (RM-MF)
G-Series HD Camera in Case (MG-MF)
55" Vividimage W HD Wall Display (RM-RR)
M-Series HD Camera (MG-MF)
Harmony iQ 2800-SLC (RM-CFE)
VividImage 27" 4K Surgical Monitor (RM-RR)
VividImage 32" 4K Surgical display (RM-RR)
Harmony iQ 2400-SLC (RM-CFE)
58" Display Monitor (8MP) (RM-RR)
Vividimage D HD Surgical Display (27") (RM-RR)
Vividimage W HD Wall Display 50-inch (RM-CFE)
A-Series HD Camera (MG-MF)
Harmony iQ 3600-SLC (RM-CFE)
Vividimage W HD Wall Display (42") (RM-RR)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device