Skytron Lite-Lok

FDA UDI

Class II (US FDA UDI)

by Microtek Medical LLC

Identity

Trade Name: Skytron Lite-Lok FDA UDI
Generic Name: Medical equipment handle cover, single-use FDA UDI
Device Name: Disposable Light Handle Cover, Double FDA UDI
Model / Reference: B1-020-99-2 FDA UDI
Description: Disposable Light Handle Cover, Double FDA UDI

Identifiers

Catalog Number: B1-020-99-2 FDA UDI
Primary DI / UDI-DI: 00748426118526 FDA UDI
FDA Product Code: FTA FDA UDI
GMDN Term: Medical equipment handle cover, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4580 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Medical equipment handle cover, single-use

Skytron Lite-Lok by Microtek Medical LLC — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Microtek Medical LLC

Sources (1)

FDA UDI b00c6c75-7550-4321-abdd-d6a722e4d7d9 35 fields · synced Jun 8, 2026