Leonhard Lang Fine Tip Pen w/Ruler- Non-Sterile

FDA UDI

Class I (US FDA UDI)

by Aspen Surgical Products, Inc.

Identity

Trade Name: Leonhard Lang Fine Tip Pen w/Ruler- Non-Sterile FDA UDI
Generic Name: Skin marking pen, single-use FDA UDI
Device Name: Intended use for surgical marking on intact skin FDA UDI
Model / Reference: SM0372B FDA UDI
Description: Intended use for surgical marking on intact skin FDA UDI

Identifiers

Primary DI / UDI-DI: 00840113214082 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Skin marking pen, single-use

Leonhard Lang Fine Tip Pen w/Ruler- Non-Sterile by Aspen Surgical Products, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Aspen Surgical Products, Inc.

Sources (1)

FDA UDI 3d6a38b9-039e-4f65-9e7b-6301458012be 34 fields · synced Jun 9, 2026