FDA Registration
Active
🇺🇸 United States
Firefly- Fluorescence Imaging Procedure Kit; 1 procedure Kit
Reg #: 3015532525
·
FEI: 3015532525
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- CARESTREAM HEALTH, INC.
- Registration Number
- 3015532525
- FEI Number
- 3015532525
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 882 Linden Ave.
- City
- Rochester
- State
- NY
- ZIP
- 14625
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191046
Owner / Operator
- Firm Name
- Carestream Health, Inc.
- Operator Number
- 9097221
- Address
- 150 Verona Street
- City
- Rochester
- State
- NY
- Postal Code
- 14608
- Country
- US
- Correspondent
- Alyssa J Haig
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Confocal Optical Imaging | OWN | Class 2 | Gastroenterology, Urology | No | 2020-02-28 |
| Light, Catheter, Fiberoptic, Glass, Ureteral | FCS | Class 2 | Gastroenterology, Urology | No | 2020-02-28 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2020-02-28 |
Proprietary Names
Firefly- Fluorescence Imaging Procedure Kit; 1 procedure Kit
Firefly- Fluorescence Imaging Procedure Kit; Box of 6 Kits
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)