FDA Registration
Active
🇺🇸 United States
Hominis® Sterile Drape for Robotic Control Unit, BOTTOM Model 6N
Reg #: 1037885
·
FEI: 1037885
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ADVANCE MEDICAL DESIGNS, INC.
- Registration Number
- 1037885
- FEI Number
- 1037885
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1241 Atlanta Industrial Dr
- City
- MARIETTA
- State
- GA
- ZIP
- 30066
- Country
- US
Regulatory Submissions
- 510(k) Number
- K850959
Owner / Operator
- Firm Name
- ADVANCE MEDICAL DESIGNS, INC.
- Operator Number
- 1037885
- Address
- 1241 ATLANTA INDUSTRIAL DR., --
- City
- Marietta
- State
- GA
- Postal Code
- 30066
- Country
- US
- Correspondent
- ANTHONY - COTTONE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2007-10-09 |
Proprietary Names
Hominis® Sterile Drape for Robotic Control Unit, BOTTOM Model 6N
Hominis® Sterile Drape for Robotic Control Unit, TOP Model 6N
Equipment Kovers
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device