FDA Registration
Active
🇺🇸 United States
Viant AS&O Holdings, LLC
Reg #: 1832228
·
FEI: 1832228
·
Expires 2026
Products
9
Proprietary Names
45
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Viant AS&O Holdings, LLC
- Registration Number
- 1832228
- FEI Number
- 1832228
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3735 NORTH ARLINGTON AVE.
- City
- Indianapolis
- State
- IN
- ZIP
- 46218
- Country
- US
Owner / Operator
- Firm Name
- Viant Medical, LLC
- Operator Number
- 9043339
- Address
- 2 Hampshire Street, Suite 202
- City
- Foxborough
- State
- MA
- Postal Code
- 02035
- Country
- US
- Correspondent
- David - Rose
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2018-12-13 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2017-12-08 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2024-09-26 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2024-09-26 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2024-09-26 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2018-12-13 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-12-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2017-10-18 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2018-12-13 |
Proprietary Names
PARS Achilles Repair Instrument Case and Lid Assembly - IND
MOD BRKT PEG DRILL
MOD BRKT TIB BROACH A-B/1-2
MOD BRKT TIB BROACH E-F/5-6
MOD BRKT TIB BROACH G-H/7-8
MOD BRKT TIB IMPACTOR PAD
MOD BRKT C-D SIZING PLATE
Persona Knee System
MOD BRKT TIB BROACH J/9-10
MOD BRKT TIB ALIGN GDE
MOD BRKT TIB CUT GDE
MOD BRKT TIB BROACH C-D/3-4
MOD BRKT A-B SIZING PLATE
MOD BRKT DRILL
MOD BRKT G-H SIZING PLATE
MOD BRKT TIBIAL DRILL GUIDE
MOD BRKT E-F SIZING PLATE
MOD BRKT TIBIAL BROACH INS/EXT
Premier Mark IV Instrument Cassette
Premier Accessory Cassette
Premier Mark VI Instrument Cassette
Premier Mark I Instrument Cassette
Persona Tibial/General Instrument Tray
GYN Instrument Tray
Superior Acetabular Retractor
Curved Retractor
Secondary Anterior Acetabular Retractor
Wide Right Angle Retractor
Narrow Right Angle Retractor
Teligen Locking Arm Assembly
LIT Single Pt Ret, Sharp/Wide
Mini Postero Retractor #4B
Tibial Retractor
Soft Tissue Protector - Tube
Blue Handle Curved Retractor
Soft Tissue Protector - Paddle
Mini Postero Retractor #7A
Anterior Acetabular Retractor
Retractor 3
VIPER PRIME Locking Post Assembly
Posterior Acetabular Retractor
S-Curved Retractor
Double Ended Retractor
LIT Offset Double Retractor Bent Right
Inferior Acetabular / Piriformis Retractor
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)