FDA.reportPublic FDA data

SUR-FIT NATURA

Primary DI
10768455106285
Brand
SUR-FIT NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
413168
Device description
SUR-FIT Natura Durahesive Flexible Skin Barrier w/Flange (overall dimension 5 in x 5 in), Tan w/Tape Collar, 2 3/4 in (70 mm)
Published
2019-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXEProtector, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXEProtector, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455106285PackageGS110In Commercial Distribution
00768455106288PrimaryGS10
00768455126446Unit of UseGS10
80768455106284Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510628510768455106285
00768455106288007684551062887684551062880768455106288
00768455126446007684551264467684551264460768455126446
8076845510628480768455106284

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal ostomy base plate, flatA non-sterile device designed with a flat surface intended to be applied and adhered to peristomal skin (typically of a normal, well-formed stoma) to facilitate the correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. It is typically self-applied by the patient. 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
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10610075097149AdaptHOLLISTER INCORPORATEDEXE2026-03-13
10610075097156AdaptHOLLISTER INCORPORATEDEXE2026-03-13
10610075097163AdaptHOLLISTER INCORPORATEDEXE2026-03-13
05056276805516EakinT.G. EAKIN LIMITEDEXE2026-02-03
05056276819063EakinT.G. EAKIN LIMITEDEXE2026-02-03
05056276819087EakinT.G. EAKIN LIMITEDEXE2026-02-03
05056276819094EakinT.G. EAKIN LIMITEDEXE2026-02-03
10610075097170CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
10610075097187CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
10610075097200AdaptHOLLISTER INCORPORATEDEXE2026-01-15
10610075097217AdaptHOLLISTER INCORPORATEDEXE2026-01-15
10610075097224AdaptHOLLISTER INCORPORATEDEXE2026-01-15
10810113576999ViveCareVIVE HEALTH LLCEXE2025-05-13
06950715505618cofoeCofoe Medical Technology Co.,LtdEXE2024-12-09
06950715505632cofoeCofoe Medical Technology Co.,LtdEXE2024-12-09
10810113577095ViveCareVIVE HEALTH LLCEXE2024-09-04
10810113577132ViveCareVIVE HEALTH LLCEXE2024-09-04
10810113577156ViveCareVIVE HEALTH LLCEXE2024-09-04
10768455209481ESENTACONVATEC, PURCHASING DEPARTMENTEXE2024-08-26
10768455209511ESENTACONVATEC, PURCHASING DEPARTMENTEXE2024-08-26
06948909454750BynexShaoxing Haoshide Medical Products Co., Ltd.EXE2024-08-22
10810113577149ViveVIVE HEALTH LLCEXE2024-07-12
06948909401280BynexShaoxing Haoshide Medical Products Co., Ltd.EXE2024-03-01
10610075094759AdaptHOLLISTER INCORPORATEDEXE2024-01-16
06926515406387BynexZhende Medical Co., Ltd.EXE2023-06-22
80768455108721EakinT.G. EAKIN LIMITEDEXE2023-05-16
80768455108738EakinT.G. EAKIN LIMITEDEXE2023-05-16
80768455109339EakinT.G. EAKIN LIMITEDEXE2023-05-16
80768455109346EakinT.G. EAKIN LIMITEDEXE2023-05-16
80768455118256EakinT.G. EAKIN LIMITEDEXE2023-05-16