Surgical Marking Pen

Basic Information

• Brand Name: Surgical Marking Pen
• Primary DI: 00845819000472
• Version / Model: 0442
• Company Name: OASIS MEDICAL, INC.
• Labeler DUNS: 194121018
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-23
• Public Version: 1
• Public Version Date: 2023-07-03
• Public Version Status: New
• Public Device Record Key: 11a00c46-54ef-4e30-a3c0-5d948ec824b2

Device Description

Surgical Marking Pen, Fine Tip, Gentian Violet.

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: 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: Yes
• Sterilization Methods: Radiation Sterilization

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
12442	Corneal marker, single-use	A manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10845819000479	GS1	Carton	10	In Commercial Distribution
Primary	00845819000472	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]