SUR-FIT NATURA

Primary DI
10768455116253
Brand
SUR-FIT NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
416954
Device description
Post Op Kit Sterile: Natura Two-Piece Urostomy, 2 3/4 in, Transparent, Standard, with Accuseal Tap, with Stomahesive Cut-To-Fit Skin Barrier
Published
2019-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
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
10768455116253PackageGS13In Commercial Distribution
00768455116256PrimaryGS10
00768455189014Unit of UseGS10
80768455116252Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845511625310768455116253
00768455116256007684551162567684551162560768455116256
00768455189014007684551890147684551890140768455189014
8076845511625280768455116252

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-422-8811cic@convatec.com
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
5
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
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

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Primary DI, Brand, Company table
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10810113577002ViveCareVIVE HEALTH LLCFON2024-09-03
10810113577019ViveCareVIVE HEALTH LLCFON2024-09-03
10810113577026ViveCareVIVE HEALTH LLCFON2024-09-03
10810113577101ViveCareVIVE HEALTH LLCFON2024-09-03
10810113577118ViveCareVIVE HEALTH LLCFON2024-09-03
10810113577125ViveCareVIVE HEALTH LLCFON2024-09-03
10768455169716ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-30
10768455169723ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-30
10768455169730ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-30
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10768455169754ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-30
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10768455111913ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455111982ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455111999ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455112033ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455113337NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114815ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114822ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114846ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114853ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114884ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114891ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455115331ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455115355ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455115720NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455118127ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29