Identity
- Trade Name
- LERNA FDA UDI
- Generic Name
- Skin adhesive protective material FDA UDI
- Device Name
- Skin Protectant Prep Pad FDA UDI
- Model / Reference
- 222-01 FDA UDI
- Description
- Skin Protectant Prep Pad FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00896180011741 FDA UDI
- FDA Product Code
- NEC FDA UDI
- GMDN Term
- Skin adhesive protective material 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin adhesive protective material
Lerna by Lernapharm (Loris) Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Skin adhesive protective material.
- Sion Biotext Medical Ltd. — SION BIOTEXT MEDICAL LTD · Class I
- Vitus — H R Pharmaceuticals, Inc. · Class I
- DropSafe™ Inject-Safe Barrier Bandage™ — HTL STREFA S A · Class I
- Sion Biotext Medical Ltd. — SION BIOTEXT MEDICAL LTD · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lernapharm (Loris) Inc
Sources (1)
- FDA UDI 751f6e91-6b21-462d-812b-89bc35980b87 33 fields · synced May 30, 2026