Marker Pad - Gentian Violet

Basic Information

• Brand Name: Marker Pad - Gentian Violet
• Primary DI: 00813465011319
• Version / Model: 7303
• Catalog Number: 7303
• Company Name: HURRICANE MEDICAL INC
• Labeler DUNS: 093377724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-05-07
• Public Version: 1
• Public Version Date: 2020-05-15
• Public Version Status: New
• Public Device Record Key: 01d81c1c-79a9-4d3f-8fa8-df485148b7b3

Device Description

Used to coat corneal markers to imprint pattern on cornea.

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: 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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMQ	Marker, Sclera	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
Unit of Use	10813465011316	GS1
Primary	00813465011319	GS1