Marking Pen

FDA UDI

Class I (US FDA UDI)

by Katena Products, Inc.

Identity

Trade Name: Marking Pen FDA UDI
Generic Name: Skin marking pen, single-use FDA UDI
Device Name: MARKING PEN FOR TREPHINE & PUNCH FDA UDI
Model / Reference: K20-2120 FDA UDI
Description: MARKING PEN FOR TREPHINE & PUNCH FDA UDI

Identifiers

Catalog Number: K20-2120 FDA UDI
Primary DI / UDI-DI: 00841668113219 FDA UDI
FDA Product Code: HRP FDA UDI
GMDN Term: Skin marking pen, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4570 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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Skin marking pen, single-use

Marking Pen by Katena Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Katena Products, Inc.

Sources (1)

FDA UDI dfe17f8f-2806-4d3e-923e-bb79e23beba3 35 fields · synced Jun 12, 2026