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
Phone
508 6719356

Products

Device Name Product Code
Laparoscope, General & Plastic Surgery GCJ

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)