FDA.reportPublic FDA data

RID

Primary DI
00810061048138
Brand
RID
Company
Oystershell Consumer Health, Inc
Model
02200005/80013
Device description
Super Max Complete Lice Elimination Kit
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LJLDetectors And Removers, Lice, (Including Combs)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJLDetectors And Removers, Lice, (Including Combs)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810061048138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810061048138008100610481388100610481380810061048138

GMDN Terms#

Term, Definition table
TermDefinition
Lice removal/prevention kitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117628199
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810061048114RID 02100260/800112022-09-23
00810061048145RID02100297/80014X2022-09-23
00810061048268RID 02200008/800262022-09-23
00810061048275RID02060165/800272022-09-23
00810061048282RID02100298/800282022-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117335301WeCare Metal Lice And Nit Removal Comb, Striped Teeth Dynarex CorporationLJL2024-03-21
00840117335295WeCare Metal Lice Comb With Handle Light Blue DYNAREX CORPORATIONLJL2024-03-21
00840117335288WeCare ClearNit Metal Lice and Nit Removal Comb, With HandleDynarex CorporationLJL2024-03-11
00840117335271WeCare Metal Lice Combs Blue DYNAREX CORPORATIONLJL2024-03-11
00057475211301BIOS LivingThermor LtdLJL2023-09-18
10057475211308BIOS LivingThermor LtdLJL2023-09-18
00663580000022LiceguardLiceguard, LLCLJL2023-08-18
00663580012025LiceguardLiceguard, LLCLJL2023-08-18
00810061048114RID Oystershell Consumer Health, IncLJL2022-09-23
00810061048145RIDOystershell Consumer Health, IncLJL2022-09-23
00810061048268RID Oystershell Consumer Health, IncLJL2022-09-23
00810061048275RIDOystershell Consumer Health, IncLJL2022-09-23
00810061048282RIDOystershell Consumer Health, IncLJL2022-09-23
00310742011234Mentholatum Kids Head Lice Removal KitMENTHOLATUM COMPANY, THELJL2021-07-01
00311917192871WalgreensWALGREEN CO.LJL2020-11-27
00311917192888Lice Killing Shampoo 8 ozWALGREEN CO.LJL2020-11-27
00311917192895WalgreensWALGREEN CO.LJL2020-11-27
00079573000762Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-28
20079573000766Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-28
00079573009192Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
00079573104910Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
00079573105948Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
00079573109168Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
10079573009199Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
10079573104917Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
10079573105945Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
10079573109165Ezy DoseAPOTHECARY PRODUCTS, LLCLJL2020-10-16
00050428359655CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLJL2020-09-18
00079573108123Acu-Life (HE)APOTHECARY PRODUCTS, LLCLJL2020-09-11
00050428315576CVS HEALTHWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLJL2020-07-29