10732ROI Dual Tip Skin Mrkr; Reg/Fine Skin Mrkr Gentian Vlt; w/Ruler/Label; PL

Basic Information

• Brand Name: 10732ROI Dual Tip Skin Mrkr; Reg/Fine Skin Mrkr Gentian Vlt; w/Ruler/Label; PL
• Primary DI: 00787551008531
• Version / Model: 10732ROI
• Catalog Number: 10732ROI
• Company Name: XODUS MEDICAL, INC.
• Labeler DUNS: 868042664
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-13
• Public Version: 2
• Public Version Date: 2023-10-17
• Public Version Status: Update
• Public Device Record Key: 4767a642-8960-44d4-b47e-08a9724a842e

Device Description

10732ROI Dual Tip Skin Marker; Regular and Fine Tip Skin Marker Gentian Violet; w/ Ruler and Labels; PL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
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	20787551008535	GS1	CASE	100	In Commercial Distribution
Primary	00787551008531	GS1

Customer Contacts

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