FDA Registration
Active
🇮🇱 Israel
Absorbent Gauze rolls/Gauze slice/Zig-zag gauze(with x-ray detectable)
Reg #: 8030128
·
FEI: 3006118668
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SION BIOTEXT MEDICAL LTD
- Registration Number
- 8030128
- FEI Number
- 3006118668
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3 Eshel St, Sapirim Industrial Park
- City
- Sderot Southern
- Country
- IL
Owner / Operator
- Firm Name
- SION BIOTEXT MEDICAL LTD
- Operator Number
- 8030128
- Address
- 3 Eshel St, Sapirim Industrial Park
- City
- Sderot
- State
- IL-NOTA
- Postal Code
- 8701002
- Country
- IL
US Agent
- Business Name
- mdi Consultants, Inc.
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd., Ste 200
- City
- Great Neck
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2018-06-26 |
Proprietary Names
Absorbent Gauze rolls/Gauze slice/Zig-zag gauze(with x-ray detectable)
Surgical Lap sponge/Abdominal sponge(with x-ray detectable)
Absorbent Surgical Gauze pad/Gauze swab/Gauze sponge(with x-ray detectable); Non woven ball(with x-ray detectable)
Absorbent Surgical Gauze ball/Peanuts ball(with x-ray detectable)
Non woven ball(with x-ray detectable)
Surgical operation towel(with x-ray detectable)
Non woven swab/Non woven pad(with x-ray detectable)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device