Identity
- Trade Name
- ElaSkin FDA UDI
- Generic Name
- Skin-cover sealant FDA UDI
- Model / Reference
- SLB180112 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001423709 FDA UDI
- 510(k) Number
- K171148 FDA UDI
- FDA Product Code
- KMF FDA UDI
- GMDN Term
- Skin-cover sealant 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
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-cover sealant
ElaSkin by Aleo Bme, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Aleo Bme, Inc.
Sources (1)
- FDA UDI 2588990c-8998-4deb-91c6-b3d7251c3883 33 fields · synced May 30, 2026