FDA.reportPublic FDA data

WeCare Metal Lice Comb With Handle Light Blue

Primary DI
00840117335295
Brand
WeCare Metal Lice Comb With Handle Light Blue
Company
DYNAREX CORPORATION
Model
1403
Device description
6.18" x 2.25"
Published
2024-03-21
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
00840117335295PackageGS1144In Commercial Distribution
00840117335301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117335295008401173352958401173352950840117335295
00840117335301008401173353018401173353010840117335301

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
1
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

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00840117307643Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106902021-04-22
00840117307667Ever-Soft Anti-Thrust Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106912021-04-22
00840117307681Ever-Soft Pommel Wedge Gel Foam Cushion 18" x 16" x 4" x 2"106802021-04-22
00840117307704Ever-Soft Pommel Wedge Gel Foam Cushion 20" x 16" x 4" x 2"106812021-04-22
00840117352476Urinary Drainage Bag Holder 11" x 11" (27.9 cm x 27.9 cm)102612019-10-09
00616784065014Ever-Soft Foam Cushion 16" x 16" x 3"106502021-04-22
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00616784065212Ever-Soft Foam Cushion 18" x 18" x 3"106522021-04-22
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00616784065410Ever-Soft Foam Cushion 20" x 18" x 3"106542021-04-22
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00616784042022DynaRest Multi-Zone Foam Mattress with Perimeter With Perimeter, 36" x 80" x 6"10420P2020-01-15
00616784070414Hydraulic Patient Lift107042019-09-30
00616784070018Electric Patient Lift107002019-09-25
00616784070117Bariatric Electric Patient Lift107012019-09-25

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Primary DI, Brand, Company table
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00840117335271WeCare Metal Lice Combs Blue DYNAREX CORPORATIONLJL2024-03-11
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