FDA Registration
Active
🇺🇸 United States
6895-1205 - Upper U-Drape, Left
Reg #: 2921578
·
FEI: 2921578
·
Expires 2025
Products
1
Proprietary Names
19
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Registration Number
- 2921578
- FEI Number
- 2921578
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 30031 AHERN AVE
- City
- UNION CITY
- State
- CA
- ZIP
- 94587
- Country
- US
Owner / Operator
- Firm Name
- Mizuho Orthopedic Systems, Inc.
- Operator Number
- 2921578
- Address
- 30031 Ahern Avenue, --
- City
- Union City
- State
- CA
- Postal Code
- 94587
- Country
- US
- Correspondent
- Mark - DeSilets
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2018-12-12 |
Proprietary Names
6895-1205 - Upper U-Drape, Left
6895TKA-L - ADANTE KNEE DRAPE SYSTEM, LEFT
6895-1204 - Upper U-Drape, Right
6895-1212 - ADANTE DAA-THA DRAPE, RIGHT
6895-1207 - Knee Drape, Left
7894-1 - Levo Sterile Cervical Drape w/Window
6855SDK-1 - PKIT HANA STERILE AATHA DRAPE KIT, 4 PC
7894-6 - LEVO STERILE CERVICAL DRAPE W/WINDOW 6CS
6895-1213 - ADANTE DAA-THA DRAPE, LEFT
6895THA-L-CS - ADANTE DAA-THA DRAPE, LEFT (5)
6895TKA-L-CS - ADANTE KNEE DRAPE SYSTEM, LEFT (5)
6895-1203 - Lower U-Drape
6895-1206 - Knee Drape, Right
6895THA-R-CS - ADANTE DAA-THA DRAPE, RIGHT (5)
6895TKA-R-CS - ADANTE KNEE DRAPE SYSTEM, RIGHT (5)
6855AUD-1 - HANA ANTERIOR HIP UPPER STERILE DRAPE
6895TKA-R - ADANTE KNEE DRAPE SYSTEM, RIGHT
6855AUD-6 - HANA ANTERIOR HIP UPPER STERILE DRAPE, 6
6855SDK-6 - PKIT HANA STERILE AATHA DRAPE KIT, 6/CS
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility