Medical Action Industries

Basic Information

• Brand Name: Medical Action Industries
• Primary DI: 10809160002803
• Version / Model: Q200
• 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: ffa79edb-8523-40e9-ac36-6369b0453a62

Device Description

Pen: Marking FP 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	20809160002800	GS1		25	In Commercial Distribution
Primary	10809160002803	GS1
Package	30809160002807	GS1		4	In Commercial Distribution

Storage Conditions

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