FDA Registration
Active
🇺🇸 United States
Vitale Silicone Foam Dressing
Reg #: 3007594734
·
FEI: 3007594734
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CellEra, LLC
- Registration Number
- 3007594734
- FEI Number
- 3007594734
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1045 Reed Road, Unit C
- City
- Monroe
- State
- OH
- ZIP
- 45050
- Country
- US
Owner / Operator
- Firm Name
- CellEra, LLC
- Operator Number
- 10029252
- Address
- 1045 Reed Road, Unit C
- City
- Monroe
- State
- OH
- Postal Code
- 45050
- Country
- US
- Correspondent
- Ken Heyl
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2009-04-23 |
Proprietary Names
Vitale Silicone Foam Dressing
Vitale Foam Heel Dressing
Vitale Non-Adhesive Foam Dressing
Vitale Adhesive Foam Dressing
Vitale Sacral Silicone Foam Dressing
Vitale Composite Dressing
Vitale Hydrocolloid Dressing
Vitale Non-Adherent Oil Emulsion Dressings
Vitale Xeroform Dressings
Vitale Petrolatum Dressings
Vitale Composite Post-Op Dressing
Establishment Types
Complaint File Establishment per 21 CFR 820.198