FDA Registration
Active
🇺🇸 United States
Dannik Specimen Retrieval Systems
Reg #: 3015775837
·
FEI: 3015775837
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- DANNIK
- Registration Number
- 3015775837
- FEI Number
- 3015775837
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3201 East Colonial Drive, Suite M3
- City
- Orlando
- State
- FL
- ZIP
- 32803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200053
Owner / Operator
- Firm Name
- DANNIK
- Operator Number
- 10061208
- Address
- 941 W Morse Blvd., Suite 100
- City
- Winter Park
- State
- FL
- Postal Code
- 32789
- Country
- US
- Correspondent
- Olga Haberland
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2020-04-21 |
Proprietary Names
Dannik Specimen Retrieval Systems
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198