FDA.reportPublic FDA data

ESTEEM SYNERGY

Primary DI
00768455104871
Brand
ESTEEM SYNERGY
Company
CONVATEC, PURCHASING DEPARTMENT
Model
405447
Device description
Esteem Synergy® Short Urostomy Pouch W/Accuseal® Tap, One Sided Comfort Panel/ 2 Accuseal® Adapters/Transparent Medium
Published
2019-04-19
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
EXHBAG, URINARY, ILEOSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXHBag, Urinary, IleostomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455104878PackageGS124In Commercial Distribution
00768455104871PrimaryGS10
00768455185276Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510487810768455104878
00768455104871007684551048717684551048710768455104871
00768455185276007684551852767684551852760768455185276

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal ostomy base plate, flatA non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. It is typically self-applied by the patient. 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
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
00768455204533ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204540ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204618ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204625ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204632ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204649ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204656ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204663ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204670ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204717ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204724ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204748ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204755ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204762ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
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