Identity
- Trade Name
- SYLKE FDA UDI
- Generic Name
- Skin-closure adhesive strip FDA UDI
- Device Name
- Adhesive Wound Closure FDA UDI
- Model / Reference
- SYL-WC-32 FDA UDI
- Description
- Adhesive Wound Closure FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860010416907 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Skin-closure adhesive strip 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin-closure adhesive strip
Sylke by SYLKE, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin-closure adhesive strip.
- UC Strip™ — Derma Sciences Canada, Inc · Class I
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- Suture Strip® — Derma Sciences Canada, Inc · Class I
- 3M™ Steri-Strip™ — 3M COMPANY · Class I
- BContak — BRIDON, CORP. · Class III
- 3M™ Steri-Strip™ — 3M COMPANY · Class I
- CareOne — Ahold U.S.A., Inc. · Class I
- DeRoyal — DEROYAL INDUSTRIES, 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
- SYLKE, Inc.
Sources (1)
- FDA UDI 0f12e42e-228d-4fea-bfbc-8a836dd9dd42 33 fields · synced Jun 9, 2026