CARDINAL HEALTH

Basic Information

• Brand Name: CARDINAL HEALTH
• Primary DI: 10885380169908
• Version / Model: 212MIL
• Catalog Number: 212MIL
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-13
• Public Version: 1
• Public Version Date: 2020-01-21
• Public Version Status: New
• Public Device Record Key: 15148e3b-5b17-41c8-90f9-8da5247216de

Device Description

Surgical Marking Pen Dual Tip Regular Tip with Labels

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• 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
FZZ	MARKER, SKIN	General, Plastic Surgery	878.4660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61575	Skin marking pen, single-use	A dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50885380169906	GS1	CASE	56	In Commercial Distribution
Package	20885380169905	GS1	BOX	12	In Commercial Distribution
Primary	10885380169908	GS1

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 0 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 0 Degrees Celsius