FDA.reportPublic FDA data

BIOS Living

Primary DI
10057475211308
Brand
BIOS Living
Company
Thermor Ltd
Model
LK130
Device description
Lice Comb Kit
Published
2023-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10057475211308PackageGS112In Commercial Distribution
20057475211305PackageGS18In Commercial Distribution
00057475211301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747521130810057475211308
2005747521130520057475211305
00057475211301000574752113010574752113010057475211301

GMDN Terms#

Term, Definition table
TermDefinition
Lice comb, manualA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
246883458
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057475032500BIOS DiagnosticsW2502026-01-19
00057475491505BIOS DiagnosticsNS1502026-01-19
20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
00057475220495BIOS Diagnostics220DI2023-09-20
00057475282493BIOS282DI2023-05-23
00057475282738BIOS LivingLH2732024-03-21
00057475282745BIOS LivingLH2742024-03-21
00057475561017BIOS LivingEP1012024-03-22
00057475561024BIOS LivingEP1022024-03-22
00057475561031BIOS LivingEP1032024-03-23
00057475561048BIOS LivingEP1042024-03-23
00057475561055BIOS LivingEP1052024-03-22
00057475561062BIOS LivingEP1062024-03-22
00057475561079BIOS LivingEP1072024-03-22
00057475561086BIOS LivingEP1082024-03-22
00057475561093BIOS LivingEP1092024-03-22
00057475561222BIOS LivingEP1222024-03-22

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
00663580000022LiceguardLiceguard, LLCLJL2023-08-18
00663580012025LiceguardLiceguard, LLCLJL2023-08-18
00810061048114RID Oystershell Consumer Health, IncLJL2022-09-23
00810061048138RID 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