FDA.reportPublic FDA data

ESTEEM+

Primary DI
10768455165602
Brand
ESTEEM+
Company
CONVATEC, PURCHASING DEPARTMENT
Model
422564
Device description
Esteem®+ Soft Convex One-Piece Urostomy V3 Precut 20Mm
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXGBAG, URINE COLLECTING, URETEROSTOMY
EXHBAG, URINARY, ILEOSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXGBag, Urine Collecting, UreterostomyGastroenterology, Urology1
EXHBag, Urinary, IleostomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455165602PackageGS12In Commercial Distribution
00768455165605PrimaryGS10
00768455198047Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845516560210768455165602
00768455165605007684551656057684551656050768455165605
00768455198047007684551980477684551980470768455198047

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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 DI, Brand, Company table
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
06974795055948MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
06974795056174MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795058116MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
06974795058390MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795058581MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795059199MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
06974795059632MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
00810040135163Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135231Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135286Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
06974567745886EMSRUNWuxi Emsrun Technology Co., Ltd.EXG2024-05-22
16974567745883EMSRUNWuxi Emsrun Technology Co., Ltd.EXG2024-05-22
10768455204530ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204530ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204547ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204547ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204615ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204615ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204622ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204622ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204639ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204639ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204646ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
10768455204646ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20