FDA Registration
Active
🇺🇸 United States
Dragonfly Pancreaticobiliary Scope
Reg #: 3015970743
·
FEI: 3015970743
·
Expires 2025
Products
4
Proprietary Names
3
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- CENTERPOINT SYSTEMS LLC
- Registration Number
- 3015970743
- FEI Number
- 3015970743
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3338 Parkway Blvd.
- City
- West Valley City
- State
- UT
- ZIP
- 84119
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233752
Owner / Operator
- Firm Name
- CenterPoint Systems LLC
- Operator Number
- 10061099
- Address
- 3338 PARKWAY BLVD
- City
- West Valley City
- State
- UT
- Postal Code
- 84119
- Country
- US
- Correspondent
- Conner Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2024-07-18 |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2024-07-18 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2024-07-18 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2024-07-18 |
Proprietary Names
Dragonfly Pancreaticobiliary Scope
Dragonfly Instrument Channel Caps
Dragonfly Digital Controller
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198