FDA Registration
Active
🇺🇸 United States
AWL, Isto Biologics
Reg #: 3006788678
·
FEI: 3006788678
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Arteriocyte Medical Systems, Inc.
- Registration Number
- 3006788678
- FEI Number
- 3006788678
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 45 South Street
- City
- Hopkinton
- State
- MA
- ZIP
- 01748
- Country
- US
Owner / Operator
- Firm Name
- Arteriocyte Medical Systems, Inc.
- Operator Number
- 10023471
- Address
- 45 South Street
- City
- Hopkinton
- State
- MA
- Postal Code
- 01748
- Country
- US
- Correspondent
- Neil Kizer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Awl | HWJ | Class 1 | Orthopedic | No | 2022-12-16 |
Proprietary Names
AWL, Isto Biologics
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility