FDA Registration Active 🇺🇸 United States

HexaVue Integration System (RM-MF)

Reg #: 3008776287 · FEI: 3008776287 · Expires 2025
Products
1
Proprietary Names
12
Establishment Types
2
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
Light, Surgical, Accessories FTA

Proprietary Names

HexaVue Integration System (RM-MF) HV 1000 IDSS-SLC (version 7 and 8) (RM-CFE) Harmony iQ 2400-SLC (RM-CFE) Harmony iQ 2800-SLC (RM-CFE) Sterile Light Handle Cover (MG-SD, SLDC-RR) Harmony iQ 3600-SLC (RM-CFE) HexaVue Integration System-Surgical Light Control (RM-MF) Sterile Handle Camera Cover (MG-SD, SLDC-RR) Universal Light Handle Cover (MG-SD, SLDC-RR) HexaVue IP In-Light Control Systems (RM-MF) HexaVue IP Integration System (RM-MF)

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198