FDA Registration
Active
🇺🇸 United States
HarmonyAir Monitor Carrier Multibar Unit (MG-RR)
Reg #: 1043572
·
FEI: 1043572
·
Expires 2025
Products
1
Proprietary Names
36
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- STERIS CORPORATION
- Registration Number
- 1043572
- FEI Number
- 1043572
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2720 GUNTER PARK DRIVE EAST
- City
- MONTGOMERY
- State
- AL
- ZIP
- 36109
- 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 |
|---|---|---|---|---|---|
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2020-11-18 |
Proprietary Names
HarmonyAir Monitor Carrier Multibar Unit (MG-RR)
5085 General Surgical Table (MG-CFE)
X-Ray Tops (MG-MF)
X-Ray Cassette Tray with Handle (MG-MF)
HarmonyAIR Monitor Carrier (MG-CFE)
Short Featherweight Leg Section with Pads for 4085, 5085 and 5085SRT Tables (MG-MF)
HarmonyAIR A-Series Suspension (MG-MF)
Lateral Braces (MG-MF)
Headrest Sections with or without Pads (MG-MF)
Morgan Pelvic Rest (MG-MF)
Table Extenders with Pads (MG-MF)
HarmonyAIR G-Series Suspension (MG-MF)
HarmonyAIR EMS (MG-MF)
Surgical Table Accessory Packages (MM-RR, MG-MF, RR)
Bariatric Urology Package (MG-MF)
5095 General Surgical Table (MG-MF)
Fluoroscent Table Extension (MG-MF)
HarmonyAIR M-Series Suspension (MG-CFE)
HarmonyAIR Utility Hub (MG-MF)
5085 Harmony Surgical Table (MG-CFE)
4085 General Surgical Table (MG-CFE)
4095 General Surgical Table (MG-MF)
Hand and Foot Controllers for Surgical Tables (MG-RR)
Cone-Shaped Headrest with/without Pads (MG-MF)
Radiolucent Table Extenders (MG-MF)
Radial AV Fistula Board with Pad (MG-MF)
Drain Pan (BF186) (MG-MF)
HarmonyAIR E-Series Suspension (MG-CFE)
Leg Sections with/without Pads (MG-MF)
HarmonyAIR EMS Shelf (MG-MF)
Gastric Bypass Table Package (BF851) (MG-MF)
ALYON Suspension System (MG-RR)
7080 General Surgical Table (MG-MF)
Imaging Table Extension (MG-MF)
Cassette Tray and Film Holder (TAB733) (MG-SD, LC-FE, PM-CM)
HarmonyAir Monitor Carrier Multibar Retrofit Kit (MG-RR)
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198