Sion Biotext Medical Ltd.

Primary DI
07290100663288
Brand
Sion Biotext Medical Ltd.
Company
SION BIOTEXT MEDICAL LTD
Model
1
Catalog number
53J505-1009-000A
Device description
The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-irritating lubricant. It is water soluble, high viscosity gel-like liquid for use as a lubricating media for insertion of medical instruments during medical procedures. It is easily rinsed off with water.The Lubricating Jelly is designed for medical purposes to lubricate body orifices, assisting in the insertion of devices for diagnostic and therapeutic purposes. It is a water-soluble jelly that spreads easily to form a translucent film and is easily washed away.Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc.The product is packaged in a convenient plastic dispenser, laminate tube with a flip top cap, in an aluminum foil/plastic laminate sachet or syringe.The lubricant is sterilized using gamma radiation.
Published
2023-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMJLubricant, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290100663288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290100663288072901006632887290100663288

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricantA substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
532775194
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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07290100665619Sion Biotext Medical Ltd.154C156-1090-0002025-07-08
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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
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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Primary DI, Brand, Company table
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00627987071429NixitMAYER LABORATORIES, INC.KMJ2025-09-16
06936603230992Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
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