FDA Registration
Active
🇩🇪 Germany
Chromophare Surgical Light System
Reg #: 8010153
·
FEI: 3006125657
·
Expires 2025
Products
1
Proprietary Names
52
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- BERCHTOLD GMBH & CO. KG
- Registration Number
- 8010153
- FEI Number
- 3006125657
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- LUDWIGSTALER STR. 25
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
US Agent
- Business Name
- STRYKER ENDOSCOPY
- Contact Name
- April Malmborg
- Address
- 5900 OPTICAL CT., --
- City
- San Jose
- State
- CA
- ZIP
- 95138
- Country
- US
- [email protected]
- Phone
- 408 4093115
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2014-12-18 |
Proprietary Names
Chromophare Surgical Light System
ACCEND Flat Panel Covers/Caps
ACCEND Lighthead Electronics Repair
ACCEND Ceiling Cover Hardware
ACCEND Suspension, FP/L/L, 1400/1300/1200mm
ACCEND Suspension, L/FP, 1050/925mm
ACCEND Rotating Soffit Assembly
ACCEND Power Supply
ACCEND L/L Classic, 1050/925mm
ACCEND Light Flat, 1050mm
ACCEND FP/L/L Classic, 1200/1050/925mm
ACCEND Handle Cover, Sterilizable
ACCEND Drop Tube, 400 mm, M12
ACCEND Drop Tube, 150 mm, M12
ACCEND Light Classic, 1050mm
ACCEND Lighthead with Flat Cardanic
ACCEND Cardanic Control Repair
ACCEND Flat Panel Hardware
ACCEND L/FP Flat, 1050/925mm
ACCEND Handle Adapter, Devon SlipOn
ACCEND LIGHT HEAD PACKAGING KIT
ACCEND Spring Arm, Flat, no stop 12-21kg
ACCEND LONG SUSPENSION PACKAGING KIT
ACCEND Drop Tube, 350mm
ACCEND Drop Tube, 400mm
ACCEND L/FP Flat, 1300/1200mm
ACCEND SPRING ARM PACKAGING KIT
ACCEND Suspension Hardware
ACCEND L/L Flat, 1300/1200mm
ACCEND Suspension Covers/Caps
ACCEND DROP TUBE HARDWARE KIT
ACCEND Spring Arm, Classic, no stop 12-21kg
ACCEND Conduit Termination Plate
ACCEND SUSPENSION PACKAGING KIT
ACCEND Spring Arm, Classic, stop 12-21kg
ACCEND Handle Adapter, Devon ScrewOn
ACCEND Drop Tube, 250 mm, M12
ACCEND Suspension, Light, 1050mm
ACCEND Spring Arm Covers/Caps
ACCEND Lighthead with Classic Cardanic
ACCEND Suspension, L/L, 1050/925mm
ACCEND Spring Arm Hardware
ACCEND Drop Tube, 150mm
ACCEND Suspension, L/FP, 1300/1200mm
ACCEND Suspension, FP/L/L, 1200/1050/925mm
ACCEND Cardanic Caps
ACCEND Flat Panel Mount
ACCEND Suspension, L/L, 1300/1200mm
ACCEND FP/L/L Flat, 1400/1300/1200mm
ACCEND L/FP Classic, 1050/925mm
ACCEND Handle Adapter, Sterilizable
ACCEND Ceiling Cover
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device