FDA Registration
Active
🇩🇪 Germany
HD 10MM 30 DEGREES IR LAPARSCOPE, AC
Reg #: 8010418
·
FEI: 3007130719
·
Expires 2025
Products
1
Proprietary Names
25
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HENKE-SASS WOLF, GMBH.
- Registration Number
- 8010418
- FEI Number
- 3007130719
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KELTENSTRASSE 1
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K910132
Owner / Operator
- Firm Name
- HENKE-SASS WOLF, GMBH.
- Operator Number
- 8010418
- Address
- Keltenstrasse 1, --
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- D-78532
- Country
- DE
- Correspondent
- MICHAEL - HERZOG
US Agent
- Business Name
- HENKE-SASS, WOLF OF AMERICA
- Contact Name
- Loretta MCHUGH
- Address
- 135 SCHOFIELD AVENUE
- City
- Dudley
- State
- MA
- ZIP
- 01571
- Country
- US
- [email protected]
- Phone
- 508 6719356
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2013-04-15 |
Proprietary Names
HD 10MM 30 DEGREES IR LAPARSCOPE, AC
5MM 30° LAPAROSCOPE, AC
5MM 30° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE
HD 5MM 0 DEGREES IR LAPARSCOPE, AC
5MM 45° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE
HD 10MM 0 DEGREES IR LAPARSCOPE, AC
5MM 30° AUTOCLAVABLE LAPAROSCOPE
10MM 30° AUTOCLAVABLE LAPAROSCOPE
2.7MM 30° AUTOCLAVABLE PEDIATRIC LAPAROSCOPE, 20CM
5MM 45° AUTOCLAVABLE LAPAROSCOPE
10MM 0° LAPAROSCOPE, AC
5MM 0° FULL SCREEN AUTOCLAVABLE LAPAROSCOPE
5MM 45° LAPAROSCOPE, AC
5MM 0° AUTOCLAVABLE LAPAROSCOPE
10MM 45° AUTOCLAVABLE LAPAROSCOPE
HD 2.9MM 30° AC PEDIATRIC LAPAROSCOPE
10MM 0° AUTOCLAVABLE LAPAROSCOPE
HD 5MM 30 DEGREES IR LAPARSCOPE, AC
10MM 45° LAPAROSCOPE, AC
2.7MM 0° AUTOCLAVABLE PEDIATRIC LAPAROSCOPE, 20CM
HD 2.9MM 0° AC PEDIATRIC LAPAROSCOPE
5MM 0° LAPAROSCOPE, AC
10MM 30° LAPAROSCOPE, AC
HD 5MM 45 DEGREES IR LAPARSCOPE, AC
HD 10MM 45 DEGREES IR LAPARSCOPE, AC
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)