FDA.reportPublic FDA data

ESTEEM+

Primary DI
00768455153169
Brand
ESTEEM+
Company
CONVATEC, PURCHASING DEPARTMENT
Model
421848
Device description
"Esteem®+ One-Piece Drainable Cut-To-Fit, Clipped, Modified Stomahesive® With Filter, 1 Comfort Panel,Standard 12"", Transparent 13/16-2 3/4"", 20-70Mm"
Published
2022-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FONBag, drainage, with adhesive, ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455153166PackageGS114In Commercial Distribution
00768455153169PrimaryGS10
00768455172580Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845515316610768455153166
00768455153169007684551531697684551531690768455153169
00768455172580007684551725807684551725800768455172580

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.

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic12@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768455201303AVELLE4466504466502023-02-22
00768455108268STOMAHESIVE0255102022-09-28
00768455101399ACTIVELIFE0209222018-11-09
00768455101405ACTIVELIFE0227502018-11-09
00768455101412ACTIVELIFE0227512018-11-09
00768455101429ACTIVELIFE0227522018-11-09
00768455101436ACTIVELIFE0227532018-11-09
00768455101443ACTIVELIFE227542018-11-09
00768455101450ACTIVELIFE0227552018-11-09
00768455101467ACTIVELIFE0227562018-11-09
00768455101474ACTIVELIFE0227572018-11-09
00768455101481ACTIVELIFE0227582018-11-09
00768455101498ACTIVELIFE0227592018-11-09
00768455101504ACTIVELIFE0227602018-11-09
00768455101511ACTIVELIFE0227612018-11-09
00768455101528ACTIVELIFE0227622018-11-16
00768455101535ACTIVELIFE0227632018-11-16
00768455101542ACTIVELIFE0227642018-11-16
00768455101559ACTIVELIFE0227652018-11-16
00768455101566ACTIVELIFE0227662018-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850087488501CeeportCEEPORT INC.FON2026-05-29
B674WIKB1401101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKB1402101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKB2001101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKE1401101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKE2001101PerilavStiehl Tech, LLCFON2026-05-13
00768455126798EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126804EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126811EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126828EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126835EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126842EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126859EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126866EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126873EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126880EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126897EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126903EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126910EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126927EakinT.G. EAKIN LIMITEDFON2023-05-16
16937359412394MaidwocWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2023-04-19
16937359412387Steawoce Wuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-21
16937359412370SteawoceWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-15
16937359412356SteadliveWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-07
00768455105670NATURACONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455111916ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455111985ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455111992ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455112036ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455113330NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29