FDA.reportPublic FDA data

SUR-FIT NATURA

Primary DI
00768455103546
Brand
SUR-FIT NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
401537
Device description
"SUR-FIT Natura® Urostomy Pouch Bend, Trans. Std. W/1-Sided Comfort Panel, 2 3/4"""
Published
2018-12-07
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
10768455103543PackageGS124In Commercial Distribution
00768455103546PrimaryGS10
00768455182718Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510354310768455103543
00768455103546007684551035467684551035460768455103546
00768455182718007684551827187684551827180768455182718

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-piece urostomy bag, open-endedA plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/changed. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic@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