FDA.reportPublic FDA data

ESTEEM

Primary DI
10768455204677
Brand
ESTEEM
Company
CONVATEC, PURCHASING DEPARTMENT
Model
423718
Device description
N/A
Published
2024-03-20
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
10768455204677PackageGS16In Commercial Distribution
00768455204670PrimaryGS10
00768455222018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845520467710768455204677
00768455204670007684552046707684552046700768455204670
00768455222018007684552220187684552220180768455222018

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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
00768455145836FLEXI-SEAL4217032019-11-18
00768455157150FLEXI-SEAL4223032019-11-18
00768455185924FLEXI-SEAL4111082022-09-09
00768455209620FLEXI-SEAL4238542023-08-16
30768455143017FLEXI-SEAL4216304216302017-04-26
00768455108565FLEXI-SEAL4111004111002016-09-01
00768455109852FLEXI-SEAL4111004111002016-09-01
00768455117178FLEXI-SEAL4180002016-09-01
00768455143016FLEXI-SEAL4216302017-05-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970944382392OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-31
06970944382583OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-30
06970944382415OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-27
06970944383740OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-27
06970944383757OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-09
00768455204533ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204540ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204618ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204625ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
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