FDA Registration
Active
🇳🇱 Netherlands
Precision S 4K Sinuscopes, 4mm x 70, 155mm, Reverse Cant
Reg #: 3008837339
·
FEI: 3008837339
·
Expires 2025
Products
5
Proprietary Names
30
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- STRYKER EMEA Supply Chain Services
- Registration Number
- 3008837339
- FEI Number
- 3008837339
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Frans Maasweg 2
- City
- Venlo Limburg
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K211202
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2021-08-30 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2021-08-30 |
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2021-08-30 |
| Endoscope, Neurological | GWG | Class 2 | Neurology | No | 2021-08-30 |
| Light, Catheter, Fiberoptic, Glass, Ureteral | FCS | Class 2 | Gastroenterology, Urology | No | 2021-08-30 |
Proprietary Names
Precision S 4K Sinuscopes, 4mm x 70, 155mm, Reverse Cant
Precision S 4K Sinuscopes, 3.1mm x 45, 170mm, Reverse Cant
Precision S 4K Sinuscopes, 3.1mm x 0, 125mm
AIM 4K Coupler, 20mm, C-Mount
Precision S 4K Sinuscopes, 4mm x 0, 180mm
Precision S 4K Sinuscopes, 4mm x 45, 155mm
Precision S 4K Sinuscopes, 3.1mm x 30, 170mm
1688 AIM 4K CAMERA HEAD WITH INTEGRATED COUPLER
1688 Pendulum Camera Head with Coupler
Precision S 4K Sinuscopes, 4mm x 30, 155mm
Precision S 4K Sinuscopes, 3.1mm x 70, 125mm
SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY, RIGHT ANGLE, 5 MM
Precision S 4K Sinuscopes, 4mm x 70, 180mm
AIM SAFELIGHT FIBER OPTIC CABLE, 5MM X 10FT / 35M
Precision S 4K Sinuscopes, 4mm x 45, 155mm, Reverse Cant
1688 AIM 4K INLINE CAMERA HEAD, C-MOUNT
Precision S 4K Sinuscopes, 3.1mm x 30, 125mm
L11 LED Light Source with AIM
Precision S 4K Sinuscopes, 4mm x 30, 155mm, Reverse Cant
Precision S 4K Sinuscopes, 3.1mm x 70, 170mm
Precision S 4K Sinuscopes, 3.1mm x 30, 170mm, Reverse Cant
Precision S 4K Sinuscopes, 3.1mm x 0, 170mm
Precision S 4K Sinuscopes, 3.1mm x 45, 170mm
Precision S 4K Sinuscopes, 4mm x 30, 180mm, Reverse Cant
Precision S 4K Sinuscopes, 4mm x 0, 155mm
Precision S 4K Sinuscopes, 4mm x 70, 155mm
SAFELIGHT FIBER OPTIC CABLE WITH ADVANCED IMAGING MODALITY, 5 MM
Precision S 4K Sinuscopes, 3.1mm x 70, 170mm, Reverse Cant
1688 AIM 4K CAMERA HEAD, C-MOUNT
1688 Camera Control Unit
Establishment Types
Export Device to the United States But Perform No Other Operation on Device