FDA Registration
Active
🇮🇱 Israel
HandX Self-Righting Needle Holder
Reg #: 3014579024
·
FEI: 3014579024
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HUMANTOUCH SURGICAL LTD.
- Registration Number
- 3014579024
- FEI Number
- 3014579024
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4 Meir Ariel St.
- City
- Netanya Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K223718
Owner / Operator
- Firm Name
- HUMANTOUCH SURGICAL LTD
- Operator Number
- 10092394
- Address
- Grand Netter Building, Meir Ariel St. 4
- City
- Netanya
- State
- Central
- Postal Code
- 4250574
- Country
- IL
- Correspondent
- Anna Zaretsky Rits
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2025-01-01 |
Proprietary Names
HandX Self-Righting Needle Holder
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device