Medical Action Industries

Basic Information

• Brand Name: Medical Action Industries
• Primary DI: 10809160004449
• Version / Model: 130
• Company Name: MEDICAL ACTION INDUSTRIES INC.
• Labeler DUNS: 092364462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-20
• Public Version: 3
• Public Version Date: 2019-09-10
• Public Version Status: Update
• Public Device Record Key: c3fa3acd-1f1e-4f9d-ace3-60e3569d35bf

Device Description

Pen: Marking Std 100/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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
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	30809160004443	GS1		4	In Commercial Distribution
Package	20809160004446	GS1		25	In Commercial Distribution
Primary	10809160004449	GS1

Storage Conditions

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