Famidoc

Basic Information

• Brand Name: Famidoc
• Primary DI: 00854314007015
• Version / Model: FDCO-V2
• Company Name: FAMIDOC USA, INC.
• Labeler DUNS: 080370811
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-29
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 08c701e2-5e28-4166-921c-a91db7503de3

Device Description

Metal Comb

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
Primary	00854314007015	GS1
Package	10854314007012	GS1		40	In Commercial Distribution