FDA UDI In Commercial Distribution 🇺🇸 United States

Sion Biotext Medical Ltd.

DI: 17290101427817 · Model: 1 · SION BIOTEXT MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50

Basic Information

Brand Name
Sion Biotext Medical Ltd.
Primary DI
17290101427817
Version / Model
1
Catalog Number
54W209-1205-912
Company Name
SION BIOTEXT MEDICAL LTD
Labeler DUNS
532775194
Distribution Status
In Commercial Distribution
Device Count in Pkg
50
Record Status
Published
Publish Date
2023-09-19
Public Version
1
Public Version Date
2023-09-27
Public Version Status
New
Public Device Record Key
4df1f7e6-70c7-4b7e-8fbc-065948478294

Device Description

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

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KOY Degreaser, Skin, Surgical

GMDN Terms

Code Name
60494 Patient medical adhesive remover

Identifiers

Type ID
Primary 17290101427817
Unit of Use 07290101427810