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DL200 Silicone Sleeve, clear

FDA UDI

Class I (US FDA UDI)

by DermLite LLC

Identity

Trade Name
DL200 Silicone Sleeve, clear FDA UDI
Generic Name
Dermatoscope, optical FDA UDI
Device Name
DL200 Silicone Sleeve, clear FDA UDI
Model / Reference
DL200CS FDA UDI
Description
DL200 Silicone Sleeve, clear FDA UDI

Identifiers

Catalog Number
DL200CS FDA UDI
Primary DI / UDI-DI
00855997006142 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

DL200 Silicone Sleeve, clear by DermLite LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dermatoscope, optical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
DermLite LLC

Sources (1)

  • FDA UDI 5177ff0f-eea2-456f-b9c6-3ee6d65f7053 35 fields · synced May 31, 2026