FDA.reportPublic FDA data

Sion Biotext Medical Ltd.

Primary DI
37290101427804
Brand
Sion Biotext Medical Ltd.
Company
SION BIOTEXT MEDICAL LTD
Model
1
Catalog number
54W211-1206-912
Device description
Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, forms a protective film to help reduce friction during removal of tapes and films. It leaves a thin breathable film on the skin, which protects it against potential damage. It dries within seconds and does not build up residue on the skin, leaving you ready to apply a new barrier. The product's discreet packaging makes it practical for traveling or useon-the-go.
Published
2023-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NECBandage, Liquid, Skin Protectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NECBandage, Liquid, Skin ProtectantGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37290101427804PrimaryGS10
07290101427803Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3729010142780437290101427804
07290101427803072901014278037290101427803

GMDN Terms#

Term, Definition table
TermDefinition
Skin adhesive protective materialA liquid preparation designed to be applied evenly over intact skin to form a synthetic polymer film, prior to application of an adhesive strip/bandage, to protect the skin during subsequent removal of the adhesive strip/bandage. It may be presented as a wipe/swab. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532775194
Device count
100
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
07290100665619Sion Biotext Medical Ltd.154C156-1090-0002025-07-08
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
37290101427811Sion Biotext Medical Ltd.154W209-1206-9122023-09-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08904428721405OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745326OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745333OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
10885632460296HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460302HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
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