Sion Biotext Medical Ltd.

Basic Information

• Brand Name: Sion Biotext Medical Ltd.
• Primary DI: 72901014283670
• Version / Model: 1
• Catalog Number: 54J506-0309-000
• Company Name: SION BIOTEXT MEDICAL LTD
• Labeler DUNS: 532775194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-25
• Public Version: 1
• Public Version Date: 2025-09-02
• Public Version Status: New
• Public Device Record Key: c83ec00d-8e53-4cbe-8d68-c38922a04f2b

Device 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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	878.4022	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	72901014283670	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]