FDA Registration
Active
🇺🇸 United States
PuraStat
Reg #: 3015528146
·
FEI: 3015528146
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- 3-D MATRIX, INC.
- Registration Number
- 3015528146
- FEI Number
- 3015528146
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1234 Chestnut St., Suite 205
- City
- Newton
- State
- MA
- ZIP
- 02464
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210098
Owner / Operator
- Firm Name
- 3D-Matrix
- Operator Number
- 10060325
- Address
- 1234 Chestnut St., Suite 205, Suite 205
- City
- Newton
- State
- MA
- Postal Code
- 02464
- Country
- US
- Correspondent
- Alan G Miskewicz
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hemostatic Device For Endoscopic Gastrointestinal Use | QAU | Class 2 | General, Plastic Surgery | No | 2022-01-25 |
Proprietary Names
PuraStat
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device