Identity
- Trade Name
- Sion Biotext Medical Ltd. FDA UDI
- Generic Name
- Patient medical adhesive remover FDA UDI
- Device Name
- Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical adhesive products. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical adhesive products. FDA UDI
Identifiers
- Catalog Number
- 54W209-1206-912 FDA UDI
- Primary DI / UDI-DI
- 37290101427811 FDA UDI
- FDA Product Code
- KOY FDA UDI
- GMDN Term
- Patient medical adhesive remover FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient medical adhesive remover
Sion Biotext Medical Ltd. by Sion Biotext Medical Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient medical adhesive remover.
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- DETACHOL — Ferndale Laboratories, Inc. · Class I
- ANS MEDICAL — Cardinalhealth · Class I
- ESENTA — CONVATEC, PURCHASING DEPARTMENT · Class I
- Adapt — Hollister Incorporated · Class I
- DETACHOL — Ferndale Laboratories, Inc. · Class I
- BodyMed — BOXOUT, LLC · Class I
- GluGone Adhesive Remover, 0.67 oz. — CHEMENCE MEDICAL INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sion Biotext Medical Ltd
Sources (1)
- FDA UDI 035c2fa9-8c1e-4366-add2-9871d5e7f661 34 fields · synced Jun 8, 2026