FDA.reportPublic FDA data

Cuteleaf

Primary DI
96979303250092
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

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
96979303250092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9697930325009296979303250092

GMDN Terms#

Term, Definition table
TermDefinition
Oral care kit, single-useA collection of various devices and supplies used for a patient's oral hygiene. It typically includes an antiseptic applicator swab, a pre-treated toothbrush, mouth swabs, and a mouthwash/oral moisturizer. Its use will improve the physical condition of the oral cavity and may help reduce the incidence of patient infection. It is typically applied by nursing staff in hospitals and institutions, or attendants in home care settings. 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
96979303250061CuteleafV1.02026-01-12
96979303250078qieduoV1.02026-01-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937935316927Sacral Silicone Superabsorbent DressingShanghai Iso Medical Products Co., Ltd.NAC2026-08-03
06979191881955OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191881962OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191881979OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191882280NanacareWAL-MART STORES, INC.NAC2026-07-31
06974692681561GUANGYIJiangsu Guangyi Medical Dressing Co.,LTD.NAC2026-07-22
01714196634404HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196635500HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196637702HydraLock SA with BorderSion Brands LLCNAC2026-07-16
10197344175963MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175970MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175987MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
00850088144314CARBOUNingbo kehu Medical Technology Co.,Ltd.NAC2026-07-08
00197344111513CURADMEDLINE INDUSTRIES, INC.NAC2026-07-03
00197998001727Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295812Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295850Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295898Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295942Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22