Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10884389007129
• Version / Model: DC102
• Catalog Number: DC102
• 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: 50f72dca-06d4-47c5-b376-9d15874bb4d9

Device Description

COVER,DOME,WHITE,QSUM ONLY

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: 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
FYF	CAP, SURGICAL	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15764	Foot-switch cover, sterile	A sterile shield, typically made of plastic in the form of a bag, placed over a foot-switch to protect the foot-switch from contamination, and to prevent potential cross-contamination between users. When used in the operating room (OR) it will provide the additional benefit of protecting the foot-switch from excessive contact with fluids that have spilled onto the floor. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40884389007120	GS1		1000	In Commercial Distribution
Primary	10884389007129	GS1

Customer Contacts

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