FDA.reportPublic FDA data

Cuteleaf

Primary DI
96979303250061
Brand
Cuteleaf
Company
Zhangzhou Win Share Co.,Ltd.
Model
V1.0
Published
2026-01-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
96979303250061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9697930325006196979303250061

GMDN Terms#

Term, Definition table
TermDefinition
Skin cleaning wipeA device consisting of an absorbent fabric pre-soaked in a liquid solution [e.g., with a detergent, alcohol, saline, hyaluronic acid (HA), plant extracts] intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and is intended for use in the home or healthcare facility. This is a single-use device.

Regulatory Flags#

DUNS number
703747799
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
96979303250009CuteleafV1.02026-01-13
96979303250016CuteleafV1.02026-01-13
96979303250047CuteleafV1.02026-01-13
96979303250085CuteleafV1.02026-01-13
96979303250115qieduoV1.02026-01-13
96979303250160CuteleafV1.02026-01-13
96979303250238CuteleafV1.02026-01-13
96979303250023CuteleafV1.02026-01-12
96979303250030CuteleafV1.02026-01-12
96979303250054CuteleafV1.02026-01-12
96979303250078qieduoV1.02026-01-12
96979303250092CuteleafV1.02026-01-12
96979303250108CuteleafV1.02026-01-12
96979303250122CuteleafV1.02026-01-12
96979303250139CuteleafV1.02026-01-12
96979303250146CuteleafV1.02026-01-12
96979303250153CuteleafV1.02026-01-12
96979303250177CuteleafV1.02026-01-12
96979303250184CuteleafV1.02026-01-12
96979303250191CuteleafV1.02026-01-12

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Primary DI, Brand, Company table
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00810226441156SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441163SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441170SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441187SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441194SuresVIVE HEALTH LLCEYQ2026-07-17
00810226441200SuresVIVE HEALTH LLCEYQ2026-07-17
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