FDA.report

ESTEEM+

Primary DI
10768455143457
Brand
ESTEEM+
Company
CONVATEC, PURCHASING DEPARTMENT
Model
421627
Device description
Esteem®+ Flex Convex, One Piece Urostomy System, Drainable, V2 Pre-Cut, 15Mm
Published
2022-09-29
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

Related Records

Contact Domains

Product Codes

CodeName
EXHBAG, URINARY, ILEOSTOMY
EZQPOUCH, COLOSTOMY

Product Code Classifications

CodeDeviceSpecialtyClass
EXHBag, Urinary, IleostomyGastroenterology, Urology1
EZQPouch, ColostomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10768455143457PackageGS13In Commercial Distribution
00768455143450PrimaryGS10
00768455197569Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845514345710768455143457
00768455143450007684551434507684551434500768455143450
00768455197569007684551975697684551975690768455197569

GMDN Terms

TermDefinition
One-piece intestinal ostomy bag, closed-endedA plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of when full. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+18004228811cic@convatec.com
+18004228811cic12@convatec.com

Regulatory Flags

DUNS number
809784593
Device count
10
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 DIBrandModelCatalogPublished
10768455203946ESTEEM4236452024-09-13
10768455209481ESENTA4238272024-08-26
10768455209511ESENTA4238262024-08-26
00768455204793GENTLECATH5106002024-04-05
00768455204823GENTLECATH5106012024-04-05
00768455204854GENTLECATH5106022024-04-05
00768455207145GENTLECATH5106032024-04-05
00768455207169GENTLECATH5106042024-04-05
00768455207206GENTLECATH5106052024-04-05
10815947021172CURE PRODUCTSHM16UK2024-03-30
10768455203922ESTEEM4236432024-03-20
10768455203939ESTEEM4236442024-03-20
10768455203953ESTEEM4236462024-03-20
10768455203960ESTEEM4236472024-03-20
10768455203977ESTEEM4236482024-03-20
10768455204004ESTEEM4236512024-03-20
10768455204011ESTEEM4236522024-03-20
10768455204028ESTEEM4236532024-03-20
10768455204035ESTEEM4236542024-03-20
10768455204059ESTEEM4236562024-03-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06974795051810MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795051896MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795053777MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795054101MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795054736MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795055504MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795056174MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795058390MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795058581MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795059632MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06950715504482cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
06950715505588cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
06950715505595cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
06950715505601cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
10768455204257ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204264ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204271ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204387ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204394ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204400ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204530ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204547ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204615ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204622ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204639ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204646ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204653ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204660ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204677ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204714ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20