Identity
- Trade Name
- SEA-CLENS FDA UDI
- Generic Name
- Secretion/excreta skin cleanser FDA UDI
- Device Name
- No-Rinse Cleanser FDA UDI
- Model / Reference
- 1061 FDA UDI
- Description
- No-Rinse Cleanser FDA UDI
Identifiers
- Catalog Number
- 1061 FDA UDI
- Primary DI / UDI-DI
- 00311701159356 FDA UDI
- FDA Product Code
- NEC FDA UDI
- GMDN Term
- Secretion/excreta skin cleanser 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
No
FDA UDI
Single Use
No
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
Dimensions & Sizes
- Size
- Total Volume — 12 Fluid Ounce FDA UDITotal Volume — 355 Milliliter FDA UDI
Category: Secretion/excreta skin cleanser
Sea-Clens by Coloplast A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
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
- Coloplast A/S
Sources (1)
- FDA UDI 5c143ab6-7e82-46af-b2e2-bbc4d6ac53de 36 fields · synced Jun 1, 2026