FDA Registration
Active
🇺🇸 United States
Teleflex Medical Inc.
Reg #: 3012481535
·
FEI: 3012481535
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Teleflex Medical Inc.
- Registration Number
- 3012481535
- FEI Number
- 3012481535
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4300 Glendale Milford Road
- City
- Cincinnati
- State
- OH
- ZIP
- 45242
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231603
Owner / Operator
- Firm Name
- Teleflex
- Operator Number
- 9062981
- Address
- 3015 Carrington Mill Blvd.
- City
- Morrisville
- State
- NC
- Postal Code
- 27560
- Country
- US
- Correspondent
- Divya Raman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Absorbable, Staple Line Reinforcement | OXC | Class 2 | General, Plastic Surgery | No | 2023-11-29 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2023-01-06 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-01-06 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2023-01-06 |
Proprietary Names
Standard Staple-Line Reinforcement
Titan SGS
Standard Trocar
Standard Tapered Bougie, 38 Fr (STB38)
Standard Precision Bougie Device
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility