FDA.report

SUR-FIT NATURA

Primary DI
10768455105752
Brand
SUR-FIT NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
411361
Device description
SUR-FIT Natura InvisiClose Drainable Pouch, 12 in, Transparent, 1-Sided Flocking, Filter, 2 1/4 in
Published
2019-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EZQPouch, Colostomy

Product Code Classifications

CodeDeviceSpecialtyClass
EZQPouch, ColostomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10768455105752PackageGS140In Commercial Distribution
00768455105755PrimaryGS10
80768455105751Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510575210768455105752
00768455105755007684551057557684551057550768455105755
8076845510575180768455105751

GMDN Terms

TermDefinition
One-piece intestinal ostomy bag, closed-endedA plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of when full. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-422-8811cic@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 DIBrandModelCatalogPublished
10768455203946ESTEEM4236452024-09-13
10768455209481ESENTA4238272024-08-26
10768455209511ESENTA4238262024-08-26
00768455204793GENTLECATH5106002024-04-05
00768455204823GENTLECATH5106012024-04-05
00768455204854GENTLECATH5106022024-04-05
00768455207145GENTLECATH5106032024-04-05
00768455207169GENTLECATH5106042024-04-05
00768455207206GENTLECATH5106052024-04-05
10815947021172CURE PRODUCTSHM16UK2024-03-30
10768455203922ESTEEM4236432024-03-20
10768455203939ESTEEM4236442024-03-20
10768455203953ESTEEM4236462024-03-20
10768455203960ESTEEM4236472024-03-20
10768455203977ESTEEM4236482024-03-20
10768455204004ESTEEM4236512024-03-20
10768455204011ESTEEM4236522024-03-20
10768455204028ESTEEM4236532024-03-20
10768455204035ESTEEM4236542024-03-20
10768455204059ESTEEM4236562024-03-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06950715504482cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
06950715505588cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
06950715505595cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
06950715505601cofoeCofoe Medical Technology Co.,LtdEZQ2024-12-09
10768455204257ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204264ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204271ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204387ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204394ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455204400ESTEEMCONVATEC, PURCHASING DEPARTMENTEZQ2024-03-20
10768455114655ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTEZQ2022-10-14
00768455157174FLEXI-SEALCONVATEC, PURCHASING DEPARTMENTEZQ2022-10-14
10768455169716ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-30
10768455169723ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-30
10768455169730ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-30
10768455169747ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-30
10768455169754ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-30
10768455102546ACTIVE LIFECONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455105677NATURACONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455111777ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455111791ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455111807ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455111821ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455111838ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455111852ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455111913ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455111982ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455111999ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455112033ESTEEM+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
10768455113337NATURA+CONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29