FDA.reportPublic FDA data

Kendall

Primary DI
10192253040128
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
9250
Catalog number
9250-
Device description
Kendall Amorphous Hydrogel Wound Dressing
Published
2023-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MGQDressing, wound and burn, hydrogel w/drug and/or biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253040126PackageGS124In Commercial Distribution
10192253040128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225304012650192253040126
1019225304012810192253040128

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, non-antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00370275900801PerioStomForward Science Technologies LLCMGQ2026-08-07
00368040753141Promiseb Topical CreamPrimus Pharmaceuticals, Inc.MGQ2026-05-01
00850058790114RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790121RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790138G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790145G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790152G4Derm PlusGel4med, Inc.MGQ2025-10-17
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790060SuprelloGel4med, Inc.MGQ2025-03-25
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00850058790091SuprelloGel4med, Inc.MGQ2025-03-25
00860013569907MuGardSoleva Pharma LLCMGQ2025-02-28
00743537000791BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000814BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000838BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000852Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000913Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000937Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000951Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000975Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000999Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001019Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001033Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001057Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001071Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001095Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000784BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000807BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000821BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000845Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01