Identity
- Trade Name
- Silicone Bandage FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, silicone FDA UDI
- Device Name
- A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed to cover a surface (e.g. a small wound), secure a dressing, or attach an object/device to the body. The silicone layer is designed to cause less allergy, cause less skin trauma than traditional pressure-sensitive adhesives, and has low adhesion to body hair for easy removal. This is a disposable device. Available in 1-inch, 2-inch, and 4-inch widths. FDA UDI
- Model / Reference
- ABST-4-22 FDA UDI
- Description
- A long, narrow, flexible band of material with an adhesive layer made of soft silicone designed to cover a surface (e.g. a small wound), secure a dressing, or attach an object/device to the body. The silicone layer is designed to cause less allergy, cause less skin trauma than traditional pressure-sensitive adhesives, and has low adhesion to body hair for easy removal. This is a disposable device. Available in 1-inch, 2-inch, and 4-inch widths. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800109203386 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Dressing-fixation skin adhesive tape, silicone FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 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: Dressing-fixation skin adhesive tape, silicone
Silicone Bandage by AP MDS Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dressing-fixation skin adhesive tape, silicone.
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- FifthPulse — Jeg & Sons Inc. · Class I
- OFFSET MODULAR HEAD PROVISIONAL — Biomet Orthopedics, Inc. · Class I
- Acanthus — ACANTHUS MEDICAL CREATIONS, LLC · Class I
- LotFancy — Henan Maidingkang Medical Technology Co., Ltd. · 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
- AP MDS Co., Ltd.
Sources (1)
- FDA UDI 81a76b22-be7f-4717-94c9-38cad88a9bbb 35 fields · synced May 30, 2026