Medical Action Industries

Basic Information

• Brand Name: Medical Action Industries
• Primary DI: 20809160022150
• Version / Model: NS300
• Company Name: MEDICAL ACTION INDUSTRIES INC.
• Labeler DUNS: 092364462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2016-08-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c99fee20-acf1-4b8d-bef3-85414b51551f

Device Description

Pen: Std Pt CHG Resistant 500/Cs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRP	PEN, MARKING, SURGICAL	Ophthalmic	886.4570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61576	Skin marking pen, single-use, non-sterile	A non-sterile, dedicated pen (typically a felt-tip pen) intended to be used to delineate areas on the skin surface of a patient (e.g., for dermatology applications) utilizing non-toxic ink. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20809160022150	GS1
Unit of Use	10809160022153	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Type: Special Storage Condition, Specify
• Special Conditions: store at room temperature