FDA Registration
Active
🇺🇸 United States
Ultracell® Ear Wick Long 9 x 24 mm
Reg #: 1211998
·
FEI: 1211998
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Beaver-Visitec International, Inc.
- Registration Number
- 1211998
- FEI Number
- 1211998
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 303 Wyman St Ste 350
- City
- Waltham
- State
- MA
- ZIP
- 02451
- Country
- US
Regulatory Submissions
- 510(k) Number
- K920357
Owner / Operator
- Firm Name
- Beaver-Visitec International, Inc.
- Operator Number
- 10033379
- Address
- 500 Totten Pond Rd, 10 CityPoint
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ear Wick | KCN | Class 1 | Ear, Nose, Throat | No | 2020-07-02 |
Proprietary Names
Ultracell® Ear Wick Long 9 x 24 mm
Ultracell® Pediatric Ear Wick Long 7 x 20 mm
Ultracell® Ear Wick 9 x15 mm
Ultracell® Ear Wick Fenestrated Long 9 x 24 mm
Ultracell® Pediatric Ear Wick Fenestrated 7 x 20 mm
Ultracell® Pediatric Eye Wick 7 x 12 mm
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility