FDA Registration
Active
🇨🇭 Switzerland
TVT Reusable Introducer
Reg #: 3003702646
·
FEI: 3003702646
·
Expires 2025
Products
2
Proprietary Names
3
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- ETHICON SARL
- Registration Number
- 3003702646
- FEI Number
- 3003702646
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- PUITS GODET 20
- City
- NEUCHATEL
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K173162
Owner / Operator
- Firm Name
- ETHICON INC.
- Operator Number
- 2210968
- Address
- 1000 US Highway 202 S.
- City
- Raritan
- State
- NJ
- Postal Code
- 08869
- Country
- US
- Correspondent
- Reynaldo Librojo
US Agent
- Business Name
- ETHICON Inc
- Contact Name
- Reynaldo Librojo
- Address
- 1000 Us Highway 202
- City
- Raritan
- State
- NJ
- ZIP
- 08869
- Country
- US
- [email protected]
- Phone
- 908 8086028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence | PWJ | Class 2 | Obstetrics/Gynecology | No | 2018-07-17 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | Class 2 | General, Plastic Surgery | No | 2018-07-17 |
Proprietary Names
TVT Reusable Introducer
TVT Reusable Catheter Guide
TVT Abdominal Guides and Couplers
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)