Pro-Paks

Basic Information

• Brand Name: Pro-Paks
• Primary DI: 10810003223439
• Version / Model: MK-9001
• Catalog Number: MK-9001
• Company Name: MICROSPECIALITIES, INC.
• Labeler DUNS: 013469890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-13
• Public Version: 1
• Public Version Date: 2019-11-21
• Public Version Status: New
• Public Device Record Key: e889e84c-486e-4925-b51a-75c724f75de5

Device Description

Standard Pen Genian Violet, 20/bx. Our surgical marking pens contain a large reservoir if medical grade non-irrating gentian violet ink.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMR	Marker, Ocular	Ophthalmic	886.4570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64415	Skin marking guide, single-use	A device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810003223439	GS1
Package	30810003223433	GS1	Box	20	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]