NATURA

Primary DI
00768455116003
Brand
NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
416929
Device description
"Post Op Kit: Natura® Two-Piece, Drainable, 4"" (100Mm), Transparent, Standard, With Invisiclose® Tail Closure, With Stomahexive® Cut-To-Fit Skin Barrier"
Published
2022-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZPRod, colostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZPRod, ColostomyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811240000SUR-FIT LOOP OSTOMY O.R. SETE. R. Squibb & Sons, Inc.1981-06-16EXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455116000PackageGS13Not in Commercial Distribution
00768455116003PrimaryGS10
00768455188888Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845511600010768455116000
00768455116003007684551160037684551160030768455116003
00768455188888007684551888887684551888880768455188888

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-piece intestinal ostomy bag, open-endedA plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The distal end of the pouch can be opened for drainage of the waste and emptied, e.g., several times per day. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
5
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
00661613006164Loop Ostomy RodMarlen Manufacturing And Development Co.EZP2026-05-03
00661613006171Loop Ostomy RodMarlen Manufacturing And Development Co.EZP2026-05-03
00661613006188Loop Ostomy RodMarlen Manufacturing And Development Co.EZP2026-05-03
00661613006195Loop Ostomy RodMarlen Manufacturing And Development Co.EZP2026-05-03
00661613006201Loop Ostomy RodMarlen Manufacturing And Development Co.EZP2026-05-03
00860002701325Barbell Loop Ostomy DeviceTOOLS FOR SURGERY, LLCEZP2023-07-17
00860002701349Barbell Loop Ostomy DeviceTOOLS FOR SURGERY, LLCEZP2023-07-17
00860002701356Barbell Loop Ostomy DeviceTOOLS FOR SURGERY, LLCEZP2023-07-17
05708932752558ColoplastColoplast A/SEZP2022-12-26
10768455116000NATURACONVATEC, PURCHASING DEPARTMENTEZP2022-09-28
00768455116010SUR-FIT NATURACONVATEC, PURCHASING DEPARTMENTEZP2019-03-22
10768455116017SUR-FIT NATURACONVATEC, PURCHASING DEPARTMENTEZP2019-03-22
00610075077670HollisterHOLLISTER INCORPORATEDEZP2016-09-21
20610075077674HollisterHOLLISTER INCORPORATEDEZP2016-09-21
20610075114058New ImageHOLLISTER INCORPORATEDEZP2016-09-21
20610075114089New ImageHOLLISTER INCORPORATEDEZP2016-09-21
20610075114119New ImageHOLLISTER INCORPORATEDEZP2016-09-21
20610075114140New ImageHOLLISTER INCORPORATEDEZP2016-09-21
00768455115501SUR-FIT LOOP OSTOMY ROD 65MMCONVATEC, PURCHASING DEPARTMENTEZP2016-09-01
10768455115508SUR-FIT LOOP OSTOMY ROD 65MMCONVATEC, PURCHASING DEPARTMENTEZP2016-09-01
00768455115518SUR-FIT LOOP OSTOMY ROD 90MMCONVATEC, PURCHASING DEPARTMENTEZP2016-09-01
00768455115983SUR-FIT NATURACONVATEC, PURCHASING DEPARTMENTEZP2016-09-01
00768455115990SUR-FIT NATURACONVATEC, PURCHASING DEPARTMENTEZP2016-09-01