FDA.reportPublic FDA data

Sion Biotext Medical Ltd.

Primary DI
07290100665619
Brand
Sion Biotext Medical Ltd.
Company
SION BIOTEXT MEDICAL LTD
Model
1
Catalog number
54C156-1090-000
Device description
Gauze impregnated with a paste containing Zinc Oxide and Glycerine.Ideal for conditions that require support and mild compression for management of venous leg ulcers and edema.
Published
2025-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITGBandage, Cast

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITGBandage, CastPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290100665619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290100665619072901006656197290100665619

GMDN Terms#

Term, Definition table
TermDefinition
Compression bandaging kitA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+97286898650customer-service@sn-medical.com

Regulatory Flags#

DUNS number
532775194
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290101428350Sion Biotext Medical Ltd.154J506-0109-0002025-08-25
72901014283670Sion Biotext Medical Ltd.154J506-0309-0002025-08-25
07290100665626Sion Biotext Medical Ltd.154C156-7590-0002025-07-08
07290100665633Sion Biotext Medical Ltd.154C257-1090-0002025-07-08
07290100665640Sion Biotext Medical Ltd.154C257-7590-0002025-07-08
17290100666156Sion Biotext Medical Ltd.153J805-3011-0002025-04-02
17290100663308Sion Biotext Medical Ltd.153J805-5001-0002023-09-19
07290100663288Sion Biotext Medical Ltd.153J505-1009-000A2023-09-19
07290100663301Sion Biotext Medical Ltd.153J805-5001-000A2023-09-19
17290101427800Sion Biotext Medical Ltd.154W211-1205-9122023-09-19
17290101427817Sion Biotext Medical Ltd.154W209-1205-9122023-09-19
37290101427804Sion Biotext Medical Ltd.154W211-1206-9122023-09-19
37290101427811Sion Biotext Medical Ltd.154W209-1206-9122023-09-19

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