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 SPRAY 8 OZ EA FDA UDI
Model / Reference: 10-1637 FDA UDI
Description: SKLAR LUBE SPRAY 8 OZ EA FDA UDI

Identifiers

Primary DI / UDI-DI: 10649111360756 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.

Service Oil and Cleaning Solution MB-301 — W & H Dentalwerk Bürmoos GmbH · Class I
ContraClean — Stryker Corp. · Class I
CURVTEK LUBRICANT, 1OZ — Biomet Orthopedics, Inc. · Class I
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Sklar Corporation

Sources (1)

FDA UDI de72e219-b1e1-4da0-9a56-46bb872f2b61 33 fields · synced Jun 7, 2026