FDA.reportPublic FDA data

SIKKARIML9

Primary DI
04987603354869
Brand
SIKKARIML9
Company
HAKUJUJI CO., LTD.
Model
35486
Catalog number
4987603354869
Device description
Yawa-Raku Pants, Firm and Long-lasting, Size ML, 9 pieces per pack
Published
2024-07-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
EYQGarment, Protective, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYQGarment, Protective, For IncontinenceGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987603354869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987603354869049876033548694987603354869

GMDN Terms#

Term, Definition table
TermDefinition
Incontinence pants linerA disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690868054
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987603331303PADOTOKO3313049876033313032024-07-11
04987603331501PADJOSEI3315049876033315012024-07-11
04987603331310PADJOSEI3313149876033313102024-07-12
04987603331402PADOTOKO3314049876033314022024-07-12
04987603331969SALVAASAICHIN3319649876033319692024-07-12
04987603331976SALVAASAICHINS3319749876033319762024-07-12
04987603332843PANTSYOHIRU3328449876033328432024-07-12
04987603332850PANTSYOYORU3328549876033328502024-07-12
04987603354876SIKKARIML183548749876033548762024-07-12
04987603354883YAWARAKAML223548849876033548832024-07-12
04987603354968SIKKARILLL835496049876033549682024-07-12
04987603354975SIKKARILLL1635497049876033549752024-07-12
04987603354982YAWARAKALLL203549849876033549822024-07-12
04987603355057OUENTM3035505049876033550572024-07-12
04987603355064OUENTL263550649876033550642024-07-12
04987603355071OUENTSM3235507049876033550712024-07-12
04987603355088OUENTML283550849876033550882024-07-12
04987603355897ANSINWFM103558949876033558972024-07-12
04987603355910ANSINWFL93559149876033559102024-07-12
04987603358416SALVAYAWARAKU3584149876033584162024-07-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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