FDA.reportPublic FDA data

Bynex

Primary DI
06948909454736
Brand
Bynex
Company
Shaoxing Haoshide Medical Products Co., Ltd.
Model
3003
Device description
Ostomy paste 60g 1 pc/box 140 boxes/carton
Published
2024-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
06948909454736PackageGS1140In Commercial Distribution
06948909454729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06948909454736069489094547366948909454736
06948909454729069489094547296948909454729

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420764429
Device count
1
DM exempt
false
Premarket exempt
true
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
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
06948909454705BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-21
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