FDA Registration
Active
🇮🇱 Israel
SuperBall
Reg #: 3016926753
·
FEI: 3016926753
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ARCURO MEDICAL LTD.
- Registration Number
- 3016926753
- FEI Number
- 3016926753
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 17 Tchelet St., Misgav Business Park
- City
- Misgav Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K180191
Owner / Operator
- Firm Name
- Arcuro Medical Ltd.
- Operator Number
- 10074120
- Address
- 17 Tchelet St., Misgav Business Park
- City
- Misgav
- State
- IL-NOTA
- Postal Code
- 2017400
- Country
- IL
- Correspondent
- Dan Shlezak
US Agent
- Business Name
- Arcuro Medical Inc.
- Contact Name
- Philip Hamann
- Address
- 4850 Tamiami Trail North, Suite 301
- City
- Naples
- State
- FL
- ZIP
- 34103
- Country
- US
- [email protected]
- Phone
- 239 8601068
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2020-05-19 |
Proprietary Names
SuperBall
Establishment Types
Manufacture Medical Device