FDA Registration
Active
🇺🇸 United States
Biotronix Healthcare Nonabsorbable Nylon Suture with Needle
Reg #: 3010131137
·
FEI: 3010131137
·
Expires 2025
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- BIOTRONIX HEALTHCARE INDUSTRIES INC.
- Registration Number
- 3010131137
- FEI Number
- 3010131137
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4700 Millenia Blvd Ste 500
- City
- Orlando
- State
- FL
- ZIP
- 32839
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080684
Owner / Operator
- Firm Name
- Biotronix Healthcare Industries Inc.
- Operator Number
- 10043487
- Address
- 4700 Millenia Blvd Suite 500
- City
- Orlando
- State
- FL
- Postal Code
- 32839
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2013-03-27 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2013-03-27 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2013-03-27 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2013-03-27 |
Proprietary Names
Biotronix Healthcare Nonabsorbable Nylon Suture with Needle
Biotronix Healthcare Nonabsorbable Polypropylene Suture with Needle
Biotronix Healthcare Nonabsorbable Polyester Suture with Needle
Biotronix Healthcare Nonabsorbable Silk Suture with Needle
Establishment Types
Repack or Relabel Medical Device