LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295137392
• Version / Model: 5512827
• Catalog Number: 5512827
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-28
• Public Version: 2
• Public Version Date: 2021-07-02
• Public Version Status: Update
• Public Device Record Key: b5d72754-167e-4476-a018-17e97f45cbc2

Device Description

LDR Head Lice Comb 1 ea

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
LJL	DETECTORS AND REMOVERS, LICE, (INCLUDING COMBS)	General Hospital	880.5960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17552	Lice comb, manual	A hand-held manual device with specially-designed teeth (tines) spaced with precision and intended to be systematically drawn through the hair, typically following the contour of the scalp, to expose and remove human head lice (Pediculus humanus capitis) and their eggs (nits) from the hair and scalp of an infested person. It is normally available non-prescription and over-the-counter (OTC). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50096295137397	GS1	CASE	12	In Commercial Distribution
Primary	00096295137392	GS1

Customer Contacts

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