FDA Registration
Active
🇨🇭 Switzerland
ETHICON SARL
Reg #: 3003702646
·
FEI: 3003702646
·
Expires 2026
Products
4
Proprietary Names
25
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ETHICON SARL
- Registration Number
- 3003702646
- FEI Number
- 3003702646
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- PUITS GODET 20
- City
- NEUCHATEL
- Country
- CH
Regulatory Submissions
- PMA Number
- P880047
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 | 2018-07-19 |
| Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | OTN | Class 2 | General, Plastic Surgery | No | 2012-01-26 |
| Barrier, Absorbable, Adhesion | MCN | Class 3 | Unknown | No | 2008-04-24 |
| Agent, Absorbable Hemostatic, Non-Collagen Based | LMG | Class 3 | General, Plastic Surgery | No | 2011-09-27 |
Proprietary Names
TVT Reusable Catheter Guide (instruments code 810061)
TVT EXACT Trocar
TVT Reusable Introducer (Instrument code 810051)
GYNECARE TVT ABBREVO Continence System
GYNECARE TVT ABBREVO and GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide
GYNECARE TVT EXACT Continence System and Trocar
GYNECARE TVT Introducer and Catheter Guide
GYNECARE TVT System
GYNECARE TVT ABBREVO Continence System and Passers and Winged Guide
GYNECARE TVT Obturator System and Passers and Winged Guide
GYNECARE TVT with Abdominal Guides System
TVT Abdominal Guides and Couplers
TVT Reusable Introducer
TVT Reusable Catheter Guide
Gynecare TVT Exact Continence System
GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
INTERCEED
GYNECARE INTERCEED Absorbable Adhesion Barrier
GYNECARE TVT Obturator
SURGICEL Fibrillar Absorbable Hemostat
SURGICEL Nu-Knit Absorbable Hemostat
SURGICEL Absorbable Hemostat
SURGICEL Powder Absorbable Hemostatic Powder
SURGICEL Endoscopic Applicator
SURGICEL Snow Absorbable Hemostat
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device