FDA.report

Kendall

Primary DI
50192253040140
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
9252
Catalog number
9252
Device description
Kendall Amorphous Hydrogel Wound Dressing
Published
2024-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253040140PackageGS112In Commercial Distribution
10192253040142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225304014050192253040140
1019225304014210192253040142

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00860013569907MuGardSoleva Pharma LLCMGQ2025-02-28
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
00743537000906Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000920Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001002Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001040Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001064Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001088Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000760BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-10-31
00743537001200Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-10-29
00743537001217Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-10-29
00370564456156Gelclair® CONCENTRATED ORAL GELNapo Pharmaceuticals, Inc.MGQ2024-09-13
50192253040102KendallCardinal Health 200, LLCMGQ2024-08-14
50192253040119KendallCardinal Health 200, LLCMGQ2024-08-14
00383160000029Dash TopicAIM MEDICAL INC.MGQ2024-08-09
00383160000098Dash TopicAIM MEDICAL INC.MGQ2024-08-09
10850058655007PeriovanceORABIO, INC.MGQ2024-05-31
20686864060776MedicomAMD Medicom IncMGQ2024-05-08
00383160000012Dash TopicAIM MEDICAL INC.MGQ2024-04-25
50192253040133KendallCardinal Health 200, LLCMGQ2024-04-15
00358962302008Canker-X Rincinol Mouth Sore RinseAlliance Pharma Inc.MGQ2024-04-05
00358962303005Canker-X Mouth Sore SprayAlliance Pharma Inc.MGQ2024-04-05
00358962301001Canker-X Mouth Sore GelAlliance Pharma Inc.MGQ2024-04-02
00370275713050OrapeuticForward Science Technologies LLCMGQ2024-02-14
00037027571305OrapeuticForward Science Technologies LLCMGQ2024-02-14