Key Surgical Skin Markers

Basic Information

• Brand Name: Key Surgical Skin Markers
• Primary DI: 00849771030485
• Version / Model: SM-300
• Catalog Number: SM300
• Company Name: KEY SURGICAL, INC.
• Labeler DUNS: 604056226
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-09
• Public Version: 4
• Public Version Date: 2024-02-13
• Public Version Status: Update
• Public Device Record Key: d11f55e4-c124-4f8c-885f-f4c77e3687c1
• Distribution End Date: 2024-02-12

Device Description

Skin Markers, Sterile, Dual tip (1 mm and 0.5 mm) with Ruler and 6 labels

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No

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
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	10849771030482	GS1	Box	50	Not in Commercial Distribution	2024-02-12
Primary	00849771030485	GS1

Customer Contacts

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