FDA.reportPublic FDA data

Biokerzon

Primary DI
16958868743069
Brand
Biokerzon
Company
Roosin Medical Co., Ltd.
Model
10cm×10cm
Device description
Hydrocolloid Dressing;10cm×10cm
Published
2026-04-27
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
NECBandage, Liquid, Skin Protectant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NECBandage, Liquid, Skin ProtectantGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26958868743066PackageGS110In Commercial Distribution
46958868743060PackageGS168In Commercial Distribution
16958868743069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2695886874306626958868743066
4695886874306046958868743060
1695886874306916958868743069

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-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; it does not contain an antimicrobial agent. The device 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. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
527587815
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16958868742147Vipflge5cm×5cm2022-09-23
16958868742154Dr.Med10cm×10cm2023-02-08
16958868752030OPTITEKNIK3cm×4cm2026-04-29
16958868743090Polynew5cm×6m2026-04-27
16958868752023ROOSIN11cm×11cm2026-04-27
16958868753006ROOSINAdhesive 11cm×25cm2026-04-27
16958868753013ROOSINAdhesive 10cm×10cm2026-04-27
16958868753020ROOSINNon-adhesive 10cm×10cm2026-04-27
16958868752016Biokerzon10cm×10cm2026-04-17
16958868744004Dr.Med10cm×10cm2022-09-23
16958868744011Polynew10cm×10cm2022-09-23
16958868743021Dr.Med5cmX5cm2024-05-13
16958868743038Dr.Med15cm×15cm2024-05-13
16958868743045Polynew5cm×5cm2024-05-13
16958868743052Polynew5cm×7.5cm2024-05-13
26958868743028Dr.Med5cmX5cm2024-05-13
26958868743035Dr.Med15cm×15cm2024-05-13
26958868743042Polynew5cm×5cm2024-05-13
26958868743059Polynew5cm×7.5cm2024-05-13
16958868742185DILUMAMED5cm×5cm2023-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850002835212Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835229Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835304Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835533Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835540Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835632Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00850002835649Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007422Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007439Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007583Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007590Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007606Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00856253007613Safe N Simple LLCSAFE N' SIMPLE LLCNEC2026-10-14
00852927004001Respiratory AccessorySunset Healthcare Solutions, Inc.NEC2026-09-09
08904428721399OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428721405OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745326OSSEOUS- Skin Closure TapeEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
08904428745333OSSEOUS- Skin Preparation PadEON MEDITECH PRIVATE LIMITEDNEC2026-03-13
10885632460296HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460302HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460319HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10885632460326HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460290HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
20885632460309HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460313HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
30885632460320HALYARDOWENS & MINOR DISTRIBUTION, INC.NEC2026-02-05
10197344042098MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
10197344042111MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
20197344042095MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26
30197344042115MEDLINEMEDLINE INDUSTRIES, INC.NEC2026-01-26