Sion Biotext Medical Ltd. 54W209-1206-912

GUDID 37290101427811

Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical adhesive products.

SION BIOTEXT MEDICAL LTD

Patient medical adhesive remover
Primary Device ID37290101427811
NIH Device Record Key035c2fa9-8c1e-4366-add2-9871d5e7f661
Commercial Distribution StatusIn Commercial Distribution
Brand NameSion Biotext Medical Ltd.
Version Model Number1
Catalog Number54W209-1206-912
Company DUNS532775194
Company NameSION BIOTEXT MEDICAL LTD
Device Count100
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290101427810 [Unit of Use]
GS137290101427811 [Primary]

FDA Product Code

KOYDegreaser, Skin, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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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