FDA Registration
Active
🇺🇸 United States
Mouth-Aid
Reg #: 3008979241
·
FEI: 3008979241
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ORTHONU, LLC
- Registration Number
- 3008979241
- FEI Number
- 3008979241
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 17 Auldwood Lane
- City
- Rumson
- State
- NJ
- ZIP
- 07760
- Country
- US
Owner / Operator
- Firm Name
- OrthoNu, LLC
- Operator Number
- 10081935
- Address
- 17 Auldwood Lane
- City
- Rumson
- State
- NJ
- Postal Code
- 07760
- Country
- US
- Correspondent
- Sima Yakoby Epstein
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2024-04-15 |
Proprietary Names
Mouth-Aid
Comfort Tape
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device