Devon

Basic Information

• Brand Name: Devon
• Primary DI: 10884521174917
• Version / Model: 31141206
• Catalog Number: 31141206
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-10-23
• Public Version Status: Update
• Public Device Record Key: ae2a38c2-feb2-4b5d-89b6-473197a606c2

Device Description

Absorbent Tray Liner

Device Characteristics

• Single Use: Yes
• 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: No
• 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
FRG	Wrap, sterilization	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61664	Instrument tray liner	A durable foam sheet intended to line the inside of an instrument tray during a surgical procedure to protect delicate or sharp clinical instruments (typically endoscopes or surgical instruments) and prevent instrument movement. It is dedicated for use with an instrument tray and not intended to be used as a drape. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521174917	GS1
Unit of Use	20884521174914	GS1

Premarket Submissions

Submission Number	Supplement Number
K893764	000

Device Sizes

Type	Value	Unit	Text
Length	26	Inch
Width	14	Inch

Storage Conditions

• Type: Special Storage Condition, Specify