FDA.reportPublic FDA data

Kendall

Primary DI
30884521007608
Brand
Kendall
Company
Cardinal Health, Inc.
Model
9251
Catalog number
9251
Device description
Amorphous Hydrogel Wound Dressing
Published
2018-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
30884521007608PackageGS112In Commercial Distribution
10884521007604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088452100760830884521007608
1088452100760410884521007604

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00743537000906Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01