Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar® FDA UDI
Generic Name: Surgical instrument maintenance lubricant FDA UDI
Device Name: SKLAR LUBE 1 GAL EA FDA UDI
Model / Reference: 10-1634 FDA UDI
Description: SKLAR LUBE 1 GAL EA FDA UDI

Identifiers

Primary DI / UDI-DI: 10649111360275 FDA UDI
FDA Product Code: FSM FDA UDI
GMDN Term: Surgical instrument maintenance lubricant FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument maintenance lubricant

Sklar® by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument maintenance lubricant.

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Sky-Lube — Skytron, LLC · Class II
Primado2 — NAKANISHI INC. · Class I
Surgical Milk — Germiphene Corp. · Class I
PREMIXSLIP (4.2oz/125ml with mister) — Ruhof Corporation · Class I
Lubricare Maintenance System — Bien-Air Dental SA · 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

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Manufacturer

Manufacturer: Sklar Corporation

Sources (1)

FDA UDI c841866d-6470-4286-ae81-86a819688ccc 33 fields · synced Jun 8, 2026