Aspen® Medication Label

FDA UDI

Class I (US FDA UDI)

by Aspen Surgical Products, Inc.

Identity

Trade Name: Aspen® Medication Label FDA UDI
Generic Name: Procedural medication labelling set FDA UDI
Device Name: Used to provide a permanent method of identifying objects in the operating room FDA UDI
Model / Reference: ML5842BN FDA UDI
Description: Used to provide a permanent method of identifying objects in the operating room FDA UDI

Identifiers

Primary DI / UDI-DI: 00840113201136 FDA UDI
FDA Product Code: MDM FDA UDI
GMDN Term: Procedural medication labelling set 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

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

Yes

FDA UDI

Category: Procedural medication labelling set

Aspen® Medication Label 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 e8336b24-9951-4bef-8c97-b9e2bc6caeb8 34 fields · synced Jun 9, 2026