Identity
- Trade Name
- 3M™ Cavilon™ FDA UDI
- Generic Name
- Synthetic-polymer liquid barrier dressing FDA UDI
- Device Name
- FREE_FROM_LATEX FDA UDI
- Model / Reference
- 3343N FDA UDI
- Description
- FREE_FROM_LATEX FDA UDI
Identifiers
- Catalog Number
- 3343N FDA UDI
- Primary DI / UDI-DI
- 00707387809577 FDA UDI
- 510(k) Number
- K955103 FDA UDI
- FDA Product Code
- KMF FDA UDI
- GMDN Term
- Synthetic-polymer liquid barrier dressing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5090 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Synthetic-polymer liquid barrier dressing
3M™ Cavilon™ by 3m Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K955103 also covers:
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
- 3M™ Cavilon™ — 3M COMPANY
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
- 3m Company
Sources (1)
- FDA UDI c208643f-47be-4a36-adf4-91f43fb81e05 36 fields · synced May 30, 2026