FDA.reportPublic FDA data

ESTEEM SYN POST OP KIT STER

Primary DI
00768455105328
Brand
ESTEEM SYN POST OP KIT STER
Company
CONVATEC, PURCHASING DEPARTMENT
Model
409345
Catalog number
409345
Device description
ESTEEM SYN POST OP KIT STER
Published
2016-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
10768455105325PackageGS14In Commercial Distribution
00768455105328PrimaryGS10
08768455105320Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510532510768455105325
00768455105328007684551053287684551053280768455105328
08768455105320087684551053208768455105320

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-piece intestinal ostomy bag, open-endedA plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The base plate remains attached around the stoma, typically for 2 to 3 days, when the pouch is removed and replaced. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
809784593
Device count
5
Premarket exempt
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
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00768455113330NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29