Pro-Paks

FDA UDI

Class I (US FDA UDI)

by Microspecialities, Inc.

Identity

Trade Name: Pro-Paks FDA UDI
Generic Name: Skin marking guide, single-use FDA UDI
Device Name: Standard Pen Genian Violet, 20/bx. Our surgical marking pens contain a large reservoir if medical grade non-irrating gentian violet ink. FDA UDI
Model / Reference: MK-9001 FDA UDI
Description: Standard Pen Genian Violet, 20/bx. Our surgical marking pens contain a large reservoir if medical grade non-irrating gentian violet ink. FDA UDI

Identifiers

Catalog Number: MK-9001 FDA UDI
Primary DI / UDI-DI: 10810003223439 FDA UDI
FDA Product Code: HMR FDA UDI
GMDN Term: Skin marking guide, 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Skin marking guide, single-use

Pro-Paks by Microspecialities, 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: Microspecialities, Inc.

Sources (1)

FDA UDI e889e84c-486e-4925-b51a-75c724f75de5 35 fields · synced May 30, 2026