FDA.reportPublic FDA data

Kytocel

Primary DI
06931132224009
Brand
Kytocel
Company
Foshan United Medical Technologies Ltd.
Model
5x5cm
Catalog number
3050
Published
2023-08-25
Public version status
Update
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
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143124000KA01 Chitosan Wound DressingFoshan United Medical Technologies, Ltd.2015-01-26KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06931132224009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06931132224009069311322240096931132224009

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421269241
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06931132220063SequaFilm PU Film DressingSQ130607OU 2026-05-09
06931132222739SequaSorb Ag+ SILVER ALGINATE WOUND DRESSINGAG14102026-05-09
06931132228007SEQUAhold WOUND CLOSURE DEVICELKB10022026-05-09
06931132201048Sequa® Cel10x10cmSQC10102023-09-18
06931132201079Sequa® Cel15x15cmSQC15152023-09-18
06931132201109Sequa® Cel2.5x45cmSQC25452023-09-18
06931132203042Sequa® Sorb10x10cmSQ1A10102023-09-18
06931132203073Sequa® Sorb10x20cmSQ1A10202023-09-18
06931132203103Sequa® Sorb2.5x30cmSQ1A25352023-09-18
06931132224030Kytocel10x10cm30512023-09-18
06931132224061Kytocel15x15cm30522023-09-18
06931132224092Kytocel2.5x45cm30562023-09-18
06931132201017Sequa® Cel5x5cmSQC05052023-08-25
06931132203011Sequa® Sorb5x5cmSQ1A05052023-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612553000163VERISHARTMANN USA, INC.FRO2026-10-01
00612553000170VERISHARTMANN USA, INC.FRO2026-10-01
00612553000187VERISHARTMANN USA, INC.FRO2026-10-01
00612553000194VERISHARTMANN USA, INC.FRO2026-10-01
00194346726707equateWAL-MART STORES, INC.FRO2026-09-30
00194346726714equateWAL-MART STORES, INC.FRO2026-09-30
10885380214714CurityCardinal Health 200, LLCFRO2026-09-30
10885380214738CurityCardinal Health 200, LLCFRO2026-09-30
00810226440944ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440951ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440968ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442542ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442559ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442566ViveCareVIVE HEALTH LLCFRO2026-09-29
00810178885329Vive CareVIVE HEALTH LLCFRO2026-09-28
10885380214707CurityCardinal Health 200, LLCFRO2026-09-28
10885380214721CurityCardinal Health 200, LLCFRO2026-09-28
10885380214745CurityCardinal Health 200, LLCFRO2026-09-28
10885380214752CurityCardinal Health 200, LLCFRO2026-09-28
10885380214769CurityCardinal Health 200, LLCFRO2026-09-28
10885380214776CurityCardinal Health 200, LLCFRO2026-09-28
10885380214783CurityCardinal Health 200, LLCFRO2026-09-28
10885380214790CurityCardinal Health 200, LLCFRO2026-09-28
10885380214806CurityCardinal Health 200, LLCFRO2026-09-28
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26