RID

Basic Information

• Brand Name: RID
• Primary DI: 00810061048282
• Version / Model: 02100298/80028
• Company Name: Oystershell Consumer Health, Inc
• Labeler DUNS: 117628199
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-23
• Public Version: 1
• Public Version Date: 2022-10-03
• Public Version Status: New
• Public Device Record Key: 3301d2a4-60cb-4743-8178-687b381074e8

Device Description

Super Max Sensitive Skin Lice Elimination Kit

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: 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
45370	Lice removal/prevention kit	A collection of non-sterile devices intended to physically and chemically remove human head lice (Pediculus humanus capitis) and/or their eggs (nits) from an infested individual, and/or to prevent (re)infestation. It includes a lice removal and/or prevention agent(s) [e.g., shampoo, solution, emulsion] and also includes additional devices, typically one or more of the following: manual lice comb, shower cap, laundry additive. It does not include lice vacuuming devices. It is normally available [non-prescription] 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	00810061048282	GS1