Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar® FDA UDI
Generic Name: Skin marking pen, single-use FDA UDI
Device Name: SKLAR SURGICAL SKIN MARKER 50 FDA UDI
Model / Reference: 10-1440 FDA UDI
Description: SKLAR SURGICAL SKIN MARKER 50 FDA UDI

Identifiers

Primary DI / UDI-DI: 50649111328303 FDA UDI
FDA Product Code: FZZ FDA UDI
GMDN Term: Skin marking pen, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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: Skin marking pen, single-use

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

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Also classified as Skin marking pen, single-use.

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NS10402 Correct Site Marker(small); Gentian Violet Ink; In Dispenser Box(50/box) — XODUS MEDICAL, INC. · Class I
Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
NSMKR7132 Dual Tip Skin Marker Gentian Reg & Fine Tip -PL — XODUS MEDICAL, INC. · Class I
Richard-Allan® Utility Marker with Labels — Aspen Surgical Products, Inc. · Class I
Richard-Allan® Fine Tip Utility Pen — Aspen Surgical Products, Inc. · 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 723643e7-3083-4353-be88-5db1e8a35328 33 fields · synced May 30, 2026