FDA.reportPublic FDA data

WeCare Metal Lice Combs Blue

Primary DI
00840117335271
Brand
WeCare Metal Lice Combs Blue
Company
DYNAREX CORPORATION
Model
1402
Device description
3.5" x 1.9"
Published
2024-03-11
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
00840117335271PackageGS112In Commercial Distribution
00840117335288PrimaryGS10
08401173352880Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117335271008401173352718401173352710840117335271
00840117335288008401173352888401173352880840117335288
08401173352880084011733528808401173352880

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
008124539
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117343764Dynacare Necessities Complete Kit13742026-05-28
00616784812137Drape Sheets, Tissue 2-ply, White, 40" x 48"81212021-09-01
00616784812236Drape Sheets81222021-09-01
00616784812335Drape Sheets81232021-09-01
00616784813134Drape Sheets, Tissue 2-ply, White, 40" x 60"81312021-09-01
00616784813233Drape Sheets81322021-09-01
00616784813332Drape Sheets81332021-09-01
00616784814131Drape Sheets, Tissue 2-ply, White81412021-09-01
00616784815039Drape Sheets, Tissue 2-ply, Blue, 40" x 90"81502021-09-01
00616784815138Drape Sheets, Tissue 2-Ply, white, 40" x 90"81512021-09-01
00616784816135Pillow Cases, Tissue / Poly 2-ply, 21" x 30", White81612021-09-01
00616784890128SecureSafe Safety Insulin Syringe89012017-10-16
00616784890425SecureSafe Safety Insulin Syringe89042017-10-16
00616784892825SecureSafe Syringes With Safety Needle, Non-Toxic, 3 ML, Luer Lock89282017-10-16
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08

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
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
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
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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