FDA.reportPublic FDA data

Cuteleaf

Primary DI
96979303250283
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
Single use
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
96979303250283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9697930325028396979303250283

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, professionalAn electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09551031940052DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940069DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940076DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940083DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940090DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940106DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940113DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940120DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940137DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940144DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940151DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940168DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940175DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940182DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940199DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940205DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940212DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940229DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940236DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940243DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940250DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940267DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940274DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940281DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940298DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22