FDA Registration
Active
🇺🇸 United States
Premier Mark VI Instrument Cassette
Reg #: 1832228
·
FEI: 1832228
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Viant AS&O Holdings, LLC
- Registration Number
- 1832228
- FEI Number
- 1832228
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3735 NORTH ARLINGTON AVE.
- City
- Indianapolis
- State
- IN
- ZIP
- 46218
- Country
- US
Regulatory Submissions
- 510(k) Number
- K972138
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 |
|---|---|---|---|---|---|
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2018-12-13 |
Proprietary Names
Premier Mark VI Instrument Cassette
Premier Mark IV Instrument Cassette
Premier Mark I Instrument Cassette
Premier Accessory Cassette
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)