FDA.reportPublic FDA data

NATURA

Primary DI
10768455105967
Brand
NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
411802
Device description
SUR-FIT Natura® Moldable Durahesive® Skin Barrier With Hydrocolloid Flexible Collar [45Mm (1 3/4" ) - Medium]
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10768455105967PackageGS110In Commercial Distribution
00768455105960PrimaryGS10
00768455187027Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510596710768455105967
00768455105960007684551059607684551059600768455105960
00768455187027007684551870277684551870270768455187027

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
+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
00768455145836FLEXI-SEAL4217032019-11-18
00768455157150FLEXI-SEAL4223032019-11-18
00768455185924FLEXI-SEAL4111082022-09-09
00768455209620FLEXI-SEAL4238542023-08-16
30768455143017FLEXI-SEAL4216304216302017-04-26
00768455108565FLEXI-SEAL4111004111002016-09-01
00768455109852FLEXI-SEAL4111004111002016-09-01
00768455117178FLEXI-SEAL4180002016-09-01
00768455143016FLEXI-SEAL4216302017-05-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226441545ViveVIVE HEALTH LLCEXE2026-08-03
00810226441552ViveVIVE HEALTH LLCEXE2026-08-03
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00610075099122CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099139CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099146CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099153CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099160CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075097142AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097159AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097166AdaptHOLLISTER INCORPORATEDEXE2026-03-13
15056276805513EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819060EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819084EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819091EakinT.G. EAKIN LIMITEDEXE2026-02-03
00610075097173CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097180CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097203AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075097210AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075097227AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075094752AdaptHOLLISTER INCORPORATEDEXE2024-01-16
00768455108725EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455108732EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455109333EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455109340EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455118250EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455139170EakinT.G. EAKIN LIMITEDEXE2023-05-16
00610075092796CeraPlusHOLLISTER INCORPORATEDEXE2023-05-12
16937359412653SteawoceWuhan Sitaili Medical Apparatus Development Co., Ltd.EXE2022-12-21
00610075053063AdaptHOLLISTER INCORPORATEDEXE2022-12-01