Identity
- Trade Name
- Sion Biotext Medical Ltd. FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- The Amorphous Hydrogel product family is intended to maintain a moist environment by donating moisture to dry or minimally exudating wounds. Viscous and non-oily formulation remains in place in the wound bed. The products are non-sterile, intended for multi-use with continuous use of up to 30 days. Not made with natural rubber latex | Non-cytotoxic | Non-irritating FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- The Amorphous Hydrogel product family is intended to maintain a moist environment by donating moisture to dry or minimally exudating wounds. Viscous and non-oily formulation remains in place in the wound bed. The products are non-sterile, intended for multi-use with continuous use of up to 30 days. Not made with natural rubber latex | Non-cytotoxic | Non-irritating FDA UDI
Identifiers
- Catalog Number
- 54J506-0109-000 FDA UDI
- Primary DI / UDI-DI
- 07290101428350 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wound hydrogel dressing, non-antimicrobial
Sion Biotext Medical Ltd. by Sion Biotext Medical Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sion Biotext Medical Ltd
Sources (1)
- FDA UDI d42a67b6-c8be-439e-a1df-422c359ad458 35 fields · synced Jun 8, 2026