Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Skin-closure adhesive strip FDA UDI
- Device Name
- SKIN CLOSURE STRIP STERILE FILAMENT REINFORCED CURL-RESISTANT BREATHABLE 0.5IN X 4IN FDA UDI
- Model / Reference
- S1047 FDA UDI
- Description
- SKIN CLOSURE STRIP STERILE FILAMENT REINFORCED CURL-RESISTANT BREATHABLE 0.5IN X 4IN FDA UDI
Identifiers
- Catalog Number
- S1047 FDA UDI
- Primary DI / UDI-DI
- 00885380027898 FDA UDI
- 510(k) Number
- K874813 FDA UDI
- FDA Product Code
- FPX 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
Yes
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
No
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
Cardinal Health by Cardinal Health 200, LLC — 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
- 3M™ Steri-Strip™ — 3M COMPANY · Class I
- 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
Cleared under the same submission
K874813 also covers:
- Aspen ® Protecto Tape Card — Aspen Surgical Products, Inc.
- Aspen® Skin Closure — Aspen Surgical Products, Inc.
- Aspen® Skin Closure — Aspen Surgical Products, Inc.
- Aspen® Skin Closure — Aspen Surgical Products, Inc.
- Aspen® Skin Closure — Aspen Surgical Products, Inc.
- Aspen® Skin Closure — Aspen Surgical Products, Inc.
- Aspen® Skin Closure — Aspen Surgical Products, Inc.
- Aspen® Skin Closure — Aspen Surgical Products, Inc.
- Sterion® Skin Closure — Aspen Surgical Products, Inc.
- Sterion® Skin Closure — Aspen Surgical Products, Inc.
- Sterion® Skin Closure — Aspen Surgical Products, Inc.
- Sterion® Skin Closure — Aspen Surgical Products, Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI 1aad4099-33a6-4c62-9463-6c60dc63008a 35 fields · synced Jun 8, 2026