Sion Biotext Medical Ltd.

Basic Information

• Brand Name: Sion Biotext Medical Ltd.
• Primary DI: 07290100665640
• Version / Model: 1
• Catalog Number: 54C257-7590-000
• Company Name: SION BIOTEXT MEDICAL LTD
• Labeler DUNS: 532775194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-08
• Public Version: 1
• Public Version Date: 2025-07-16
• Public Version Status: New
• Public Device Record Key: 364e3c0e-0c67-44d4-b623-2c00545a913c

Device Description

Gauze impregnated with a paste containing Zinc Oxide and Calamine. Ideal for conditions that require support and mild compression for management of venous leg ulcers and edema

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: No
• 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
ITG	Bandage, Cast	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58983	Compression bandaging kit	A collection of various types of bandages intended for use in the treatment of venous leg ulcers, and related conditions, by sequential bandage application to provide graduated ascending-decreasing compression from the ankle to the knee. Typically the bandages are applied in a sequence of layers: a padding/exudate absorbing layer (e.g., polyester), a retention layer (e.g., cotton/polyester/elastane), a compression layer (e.g., viscose/polyester covered elastane) and a self-adherent compression/outer retention layer (e.g., latex/polyester/elastane). It is intended to be applied by a healthcare professional for use in the home and healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290100665640	GS1

Customer Contacts

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