FDA.reportPublic FDA data

ESTEEM+

Primary DI
10768455165213
Brand
ESTEEM+
Company
CONVATEC, PURCHASING DEPARTMENT
Model
422540
Device description
Esteem®+ Soft Convex One-Piece Drainable V1 Pre-Cut 30Mm
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
FONBag, drainage, with adhesive, ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXGBag, Urine Collecting, UreterostomyGastroenterology, Urology1
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455165213PackageGS120In Commercial Distribution
00768455165216PrimaryGS10
00768455197804Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845516521310768455165213
00768455165216007684551652167684551652160768455165216
00768455197804007684551978047684551978040768455197804

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
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
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
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
00610075000975PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075000982PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075000999PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075001002PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039180PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039197PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039210PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039227PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039258PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039265PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039272PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039289PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039296PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039302PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039319PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039326PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039333PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075061846PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075061853PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075061860PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075064441PremierHOLLISTER INCORPORATEDEXG2022-12-01