FDA Registration
Active
🇺🇸 United States
Y7797 ARC BEAR ICE WRAP
Reg #: 3006852457
·
FEI: 3006852457
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TOMY International
- Registration Number
- 3006852457
- FEI Number
- 3006852457
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2021 9TH ST. S.E.
- City
- Dyersville
- State
- IA
- ZIP
- 52040
- Country
- US
Owner / Operator
- Firm Name
- TOMY International
- Operator Number
- 9086544
- Address
- 2021 9th Street S.E.
- City
- Dyersville
- State
- IA
- Postal Code
- 52040
- Country
- US
- Correspondent
- Kenneth Li
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2018-06-04 |
Proprietary Names
Y7797 ARC BEAR ICE WRAP
Y7789 ARC Ice Pack
P17498 Gel Pack
Establishment Types
Complaint File Establishment per 21 CFR 820.198