FDA.reportPublic FDA data

Bynex

Primary DI
06948909454705
Brand
Bynex
Company
Shaoxing Haoshide Medical Products Co., Ltd.
Model
3002
Device description
Ostomy powder 28g 1 bottle/box 150boxes/carton
Published
2024-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EZRCement, Stomal Appliance, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZRCement, Stomal Appliance, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06948909454712PackageGS1150In Commercial Distribution
06948909454705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948909454712069489094547126948909454712
06948909454705069489094547056948909454705

GMDN Terms#

Term, Definition table
TermDefinition
Peristomal/periwound dressingA non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the seal of a stomal appliance or wound dressing. The device is typically available in a variety of forms including cream, paste in a tube or other applicator, paste in ready formed strips, or powder. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
420764429
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
06948909456020N/AP169C1BK2024-11-25
06948909456044N/AP169C2BK2024-11-25
06948909456068N/AP169C3BK2024-11-25
06948909456082N/AP169C4BK2024-11-25
06948909456105N/AP169C5BK2024-11-25
06948909456129N/AP169C6BK2024-11-25
06948909456143N/AP169C20BK2024-11-25
06948909456181N/AP169C22BK2024-11-25
06948909456204N/AP169C23BK2024-11-25
06948909456228N/AP169C24BK2024-11-25
06948909456242N/AP169C15BK2024-11-25
06948909456280N/AP169C17BK2024-11-25
06948909456303N/AP169C18BK2024-11-25
06948909456327N/AP169C19BK2024-11-25
06948909456341N/AP169C25BK2024-11-25
06948909456365N/AP169C26BK2024-11-25
06948909456389N/AP169C27BK2024-11-25
06948909456402N/AP169C28BK2024-11-25
06948909456426N/AP169C29BK2024-11-25
06948909456440N/AP169C32BK2024-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950715505984cofoeCofoe Medical Technology Co.,LtdEZR2025-02-18
06950715505649cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06950715505656cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06950715505663cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06950715505670cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06948909454729BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-22
06948909454736BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-22
06948909454712BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-21
00610075205479AdaptHOLLISTER INCORPORATEDEZR2022-12-01
00610075793013AdaptHOLLISTER INCORPORATEDEZR2022-12-01
00610075079100Karaya 5HOLLISTER INCORPORATEDEZR2022-12-01
00610075084166SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
10610075068057SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
20610075079104Karaya 5HOLLISTER INCORPORATEDEZR2022-12-01
10610075084163SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
20610075205473AdaptHOLLISTER INCORPORATEDEZR2022-12-01
10610075793010AdaptHOLLISTER INCORPORATEDEZR2022-12-01
20610075068054SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
00612479227286McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-22
00612479227309McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-22
00612479227316McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-18
00612479227330McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-18
00612479227323McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-18
00612479227347McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-18
00612479227224McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09
00612479227248McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09
00612479227262McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09
00612479227231McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09
00612479227255McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09
00612479227279McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09