Devon

Basic Information

• Brand Name: Devon
• Primary DI: 30884521049806
• Version / Model: 31146010
• Catalog Number: 31146010
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-23
• Public Version: 2
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: 2a8c79de-c642-4899-a045-de790200411f

Device Description

Surgical Site Mini-Marker

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
61576	Skin marking pen, single-use, non-sterile	A non-sterile, dedicated pen (typically a felt-tip pen) intended to be used to delineate areas on the skin surface of a patient (e.g., for dermatology applications) utilizing non-toxic ink. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521049809	GS1	CASE	200	In Commercial Distribution
Primary	30884521049806	GS1
Package	10884521049802	GS1	PACK_OR_INNER_PACK	100	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify