FDA.reportPublic FDA data

WeCare ClearNit Metal Lice and Nit Removal Comb, With Handle

Primary DI
00840117335288
Brand
WeCare ClearNit Metal Lice and Nit Removal Comb, With Handle
Company
Dynarex Corporation
Model
1402
Device description
"3.5"" x 1.9"" "
Published
2024-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840117335271PackageGS1144In Commercial Distribution
00840117335288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

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

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.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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Primary DI, Brand, Company table
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