Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10884389952344
• Version / Model: MED457
• Catalog Number: MED457
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c507f56b-fd97-4a92-b2b1-d273fa3c1e15

Device Description

EENT COMBO PACK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
LRO	General surgery tray	General, Plastic Surgery	878.4370	2
KKX	Drape, surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
39230	ENT surgical drape	A protective covering made of natural or synthetic materials, or both, designed to isolate a surgical site from contamination (e.g., microbial, substance) during an ear/nose/throat (ENT) procedure. It will typically be shaped for this purpose. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40884389952345	GS1		20	In Commercial Distribution
Primary	10884389952344	GS1

Customer Contacts

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