FDA.reportPublic FDA data

Sion Biotext Medical Ltd.

Primary DI
37290101427811
Brand
Sion Biotext Medical Ltd.
Company
SION BIOTEXT MEDICAL LTD
Model
1
Catalog number
54W209-1206-912
Device description
Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical adhesive products.
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
KOYDegreaser, Skin, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOYDegreaser, Skin, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37290101427811PrimaryGS10
07290101427810Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3729010142781137290101427811
07290101427810072901014278107290101427810

GMDN Terms#

Term, Definition table
TermDefinition
Patient medical adhesive removerA liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. 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
37290101427804Sion Biotext Medical Ltd.154W211-1206-9122023-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00616784150529Adhesive Tape Remover Pads, For Professional and Hospital Use Dynarex CorporationKOY2025-09-26
17290101427817Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKOY2023-09-19
00616784150826Electrode Skin Prep PadsDynarex CorporationKOY2022-05-10
00810180842716Electrode Skin Prep PadsDynarex CorporationKOY2022-05-10
00616784150819Electrode Skin Prep PadsDYNAREX CORPORATIONKOY2022-05-10
00714196390004Adhesive Tape Remover PadsSion Brands LLCKOY2021-09-09
18054655031840SafePrepSPES MEDICA SPAKOY2021-08-05
08054655031843SafePrepSPES MEDICA SRLKOY2021-08-05
10714196821000Adhesive Tape Remover PadsSion Brands LLCKOY2020-09-01
00310819000475PDI® Electrode Prep PadPROFESSIONAL DISPOSABLES INTERNATIONAL, INC.KOY2020-08-03
10310819000472PDI® Electrode Prep PadPROFESSIONAL DISPOSABLES INTERNATIONAL, INC.KOY2020-08-03
18054655026020Tech StickSPES MEDICA SPAKOY2019-10-23