FDA Registration
Active
🇺🇸 United States
Dukal Sterile Petrolatum Dressing
Reg #: 2435946
·
FEI: 1000137528
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- DUKAL LLC
- Registration Number
- 2435946
- FEI Number
- 1000137528
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2 Fleetwood Ct.
- City
- Ronkonkoma
- State
- NY
- ZIP
- 11779
- Country
- US
Regulatory Submissions
- 510(k) Number
- K850241
Owner / Operator
- Firm Name
- DUKAL LLC
- Operator Number
- 9005925
- Address
- 2 Fleetwood Ct, --
- City
- Ronkonkoma
- State
- NY
- Postal Code
- 11779
- Country
- US
- Correspondent
- Kara - Mckigney
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2016-03-16 |
Proprietary Names
Dukal Sterile Petrolatum Dressing
Dukal Sterile Oil Emulsion Dressing
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility