FDA Registration
Active
🇺🇸 United States
Extend Synthetic Implants (0.4mm x 2mm)
Reg #: 1211998
·
FEI: 1211998
·
Expires 2025
Products
1
Proprietary Names
5
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
- K013613
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 |
|---|---|---|---|---|---|
| Plug, Punctum | LZU | Class U | Unknown | No | 2013-04-11 |
Proprietary Names
Extend Synthetic Implants (0.4mm x 2mm)
Extend Synthetic Implants (0.3mm x 2mm)
Extend Synthetic Implants (0.2mm x 2mm)
Extend Synthetic Implants (0.5mm x 2mm)
Extend Synthetic Implants (Variety Pack)
Establishment Types
Complaint File Establishment per 21 CFR 820.198