Sion Biotext Medical Ltd. 53J505-1009-000A

GUDID 07290100663288

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.

SION BIOTEXT MEDICAL LTD

General-body orifice lubricant
Primary Device ID07290100663288
NIH Device Record Key8b8481f2-ee82-4c7a-ab7e-3ca85eb9c80c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSion Biotext Medical Ltd.
Version Model Number1
Catalog Number53J505-1009-000A
Company DUNS532775194
Company NameSION BIOTEXT MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com
Phone+97286898650
Emailcustomer-service@sn-medical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290100663288 [Primary]

FDA Product Code

KMJLubricant, Patient

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


[07290100663288]

Radiation Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-27
Device Publish Date2023-09-19

On-Brand Devices [Sion Biotext Medical Ltd.]

37290101427811Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical ad
37290101427804Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, form
17290101427817Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical ad
17290101427800Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, form
07290100663301The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-ir
07290100663288The Lubricating Jelly is sterile, clear, colorless, non-sticky, non-greasy, non-staining, non-ir

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