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IceCap Covers for Nailio, 50-pack
FDA UDIEUDAMEDClass I (US FDA UDI)
by DermLite LLC
Identity
- Trade Name
- IceCap Covers for Nailio, 50-pack FDA UDI
- Generic Name
- Dermatoscope, optical FDA UDI
- Device Name
- Disposable plastic faceplate sleeves for Nailio base FDA UDI
- Model / Reference
- ICNL1-50 FDA UDI
- Description
- Disposable plastic faceplate sleeves for Nailio base FDA UDI
Identifiers
- Catalog Number
- ICNL1-50 FDA UDI
- Primary DI / UDI-DI
- 00850017651135 FDA UDI
- FDA Product Code
- KYT FDA UDI
- GMDN Term
- Dermatoscope, optical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6350 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dermatoscope, optical
IceCap Covers for Nailio, 50-pack by DermLite LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dermatoscope, optical.
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- Diagnostix™ — American Diagnostic Corporation · Class I
- Diagnostix™ — American Diagnostic Corporation · Class I
- Diagnostix™ — American Diagnostic Corporation · Class I
- Diagnostix™ — American Diagnostic Corporation · Class I
- Diagnostix™ — American Diagnostic Corporation · Class I
- HEINE diSTANCE — Heine Optotechnik GmbH & Co. KG · Class I
- Diagnostix™ — American Diagnostic Corporation · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DermLite LLC
Sources (2)
- FDA UDI 09cbfaba-dc97-4a09-b29d-f55f3a8b7569 35 fields · synced Jun 1, 2026
- EUDAMED 1 fields · synced May 22, 2026