STRADIS HEALTHCARE

Basic Information

• Brand Name: STRADIS HEALTHCARE
• Primary DI: M7525250390
• Version / Model: 525-039
• Company Name: STRADIS MEDICAL, LLC
• Labeler DUNS: 174262477
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-31
• Public Version: 2
• Public Version Date: 2023-02-07
• Public Version Status: Update
• Public Device Record Key: 7e925759-cdfc-40c3-8042-e0cf7903ed7f
• Distribution End Date: 2023-02-06

Device Description

SKIN MARKER PACKAGED

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: 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
32313	Skin marking pen, reusable	A dedicated pen (typically a felt-tip 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. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7525250390	HIBCC

Customer Contacts

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