RMAC Surgical

Basic Information

• Brand Name: RMAC Surgical
• Primary DI: 07540277010041
• Version / Model: SPL-18401
• Company Name: RMAC Surgical, Inc
• Labeler DUNS: 203768551
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-06
• Public Version: 4
• Public Version Date: 2026-04-23
• Public Version Status: Update
• Public Device Record Key: f3480e1d-91b8-40a9-a009-4280fd9294f5

Device Description

Sterile permanent waterproof utility markers

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: Yes
• 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
64415	Skin marking guide, single-use	A device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540277010041	GS1
Package	10754027701002	GS1	Case	100	Not in Commercial Distribution	2026-02-03
Package	17540277010048	GS1	Case	100	In Commercial Distribution
Package	17540277999978	GS1	Carton	1000	In Commercial Distribution

Customer Contacts

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