FDA Registration
Active
🇮🇱 Israel
SION BIOTEXT MEDICAL LTD
Reg #: 8030128
·
FEI: 3006118668
·
Expires 2026
Products
14
Proprietary Names
8
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- SION BIOTEXT MEDICAL LTD
- Registration Number
- 8030128
- FEI Number
- 3006118668
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3 Eshel St, Sapirim Industrial Park
- City
- Sderot Southern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K142473
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 |
|---|---|---|---|---|---|
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2010-03-25 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2009-05-04 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2025-08-18 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2020-10-05 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2024-06-27 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2017-10-31 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2017-10-31 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2018-06-26 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2021-12-20 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 1996-10-01 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2018-06-26 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2011-10-26 |
| Degreaser, Skin, Surgical | KOY | Class 1 | General, Plastic Surgery | No | 2010-10-27 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2024-04-29 |
Proprietary Names
CerviLube
Surgical Lap sponge/Abdominal sponge(with x-ray detectable)
Absorbent Surgical Gauze ball/Peanuts ball(with x-ray detectable)
Absorbent Surgical Gauze pad/Gauze swab/Gauze sponge(with x-ray detectable); Non woven ball(with x-ray detectable)
Non woven ball(with x-ray detectable)
Absorbent Gauze rolls/Gauze slice/Zig-zag gauze(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