FDA.reportPublic FDA data

NATURA

Primary DI
00768455105809
Brand
NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
411489
Device description
"SUR-FIT Natura® Drainable Pouch, 12"" Opaque, 2 Side Flocking, With Filter 1 1/4"""
Published
2022-09-28
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
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
10768455105806PackageGS120In Commercial Distribution
00768455105809PrimaryGS10
00768455186839Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510580610768455105806
00768455105809007684551058097684551058090768455105809
00768455186839007684551868397684551868390768455186839

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
+18004228811cic12@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
20
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
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
00768455126798EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126804EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126811EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126828EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126835EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126842EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126859EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126866EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126873EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126880EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126897EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126903EakinT.G. EAKIN LIMITEDFON2023-05-16
00768455126910EakinT.G. EAKIN LIMITEDFON2023-05-16
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
00768455111916ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455111985ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455111992ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455112036ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455113330NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455114818ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29