Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10888277368804
• Version / Model: 70138003R
• Catalog Number: 70138003R
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-13
• Public Version: 1
• Public Version Date: 2022-05-23
• Public Version Status: New
• Public Device Record Key: 7927118a-8514-4527-a4d7-d328f2e64985

Device Description

7013-8003 POWERED DISSECTOR BLADE,IRRI

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NLY	Microdebrider, ent, high speed, single use, reprocessed	Ear, Nose, Throat	874.4140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45526	Diamond ENT bur, reprocessed	A rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into an appropriate handpiece that provides the rotation allowing the user to incise or remove bone in the ear, nose, or throat area during an ear/nose/throat (ENT) procedure. It can be used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888277368801	GS1	CASE	6	In Commercial Distribution
Primary	10888277368804	GS1

Customer Contacts

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