NATURA

GUDID 10768455116000

Post Op Kit: Natura® Two-Piece, Drainable, 4" (100Mm), Transparent, Standard, With Invisiclose® Tail Closure, With Stomahexive® Cut-To-Fit Skin Barrier

CONVATEC, PURCHASING DEPARTMENT

Multiple-piece intestinal ostomy bag, open-ended

• Primary Device ID: 10768455116000
• NIH Device Record Key: d10a5450-23f1-410b-a398-4ca0af5210f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATURA
• Version Model Number: 416929
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com
• Phone: +18004228811
• Email: cic@convatec.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00768455116003 [Primary]
GS1	00768455188888 [Unit of Use]
GS1	10768455116000 [Package]; Contains: 00768455116003; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811240

FDA Product Code

• EZP: Rod, colostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-06
• Device Publish Date: 2022-09-28

On-Brand Devices [NATURA]

• 10768455116031: Post Op Kit: Natura® Two-Piece Urostomy, 1 3/4" (45Mm), Transparent, Standard, With Accuseal®
• 10768455116000: Post Op Kit: Natura® Two-Piece, Drainable, 4" (100Mm), Transparent, Standard, With Invisiclose
• 10768455115942: Post Op Kit: Natura® Two-Piece, Drainable, 2 1/4" (57Mm), Transparent, Standard, With Invisicl
• 10768455115935: Post Op Kit: Natura® Two-Piece, Drainable, 2 1/4" (57Mm), Transparent, Standard, With Invisiclo
• 10768455115928: Post Op Kit: Natura® Two-Piece, Drainable, 2 1/4" (57Mm), Transparent, Standard, With Invisiclo
• 10768455115904: Post Op Kit: Natura® Two-Piece, Drainable, 1 3/4" (45Mm), Transparent, Standard, With Invisicl
• 10768455106018: SUR-FIT Natura® Moldable Stomahesive® Skin Barrier With Hydrocolloid Flexible Collar [70Mm (2
• 10768455106001: SUR-FIT Natura® Moldable Durahesive® Skin Barrier With Hydrocolloid Flexible Collar [70Mm (2 3
• 10768455105998: SUR-FIT Natura® Moldable Stomahesive® Skin Barrier With Hydrocolloid Flexible Collar [57Mm (2
• 10768455105974: SUR-FIT Natura® Moldable Stomahesive® Skin Barrier With Hydrocolloid Flexible Collar [45Mm (1
• 10768455105967: SUR-FIT Natura® Moldable Durahesive® Skin Barrier With Hydrocolloid Flexible Collar [45Mm (1 3
• 10768455105950: SUR-FIT Natura® Moldable Stomahesive® Skin Barrier With Hydrocolloid Flexible Collar [45Mm (1
• 10768455105943: SUR-FIT Natura® Moldable Durahesive® Skin Barrier With Hydrocolloid Flexible Collar [45Mm (1 3
• 10768455105844: SUR-FIT Natura® Drainable Pouch, 12" Opaque, 2 Side Flocking, With Filter 2 3/4"
• 10768455105837: SUR-FIT Natura® Drainable Pouch, 12" Opaque, 2 Side Flocking, With Filter 2 1/4"
• 10768455105820: SUR-FIT Natura® Drainable Pouch, 12" Opaque, 2 Side Flocking, With Filter 1 3/4"
• 10768455105813: SUR-FIT Natura® Drainable Pouch, 12" Opaque, 2 Side Flocking, With Filter 1 1/2"
• 10768455105806: SUR-FIT Natura® Drainable Pouch, 12" Opaque, 2 Side Flocking, With Filter 1 1/4"
• 10768455105691: SUR-FIT Natura® Drainable Pouch, 10" Opaque, 2 Side Flocking, With Filter 2 3/4"
• 10768455105684: SUR-FIT Natura® Drainable Pouch, 10" Opaque, 2 Side Flocking, With Filter 2 1/4"
• 10768455105660: SUR-FIT Natura® Drainable Pouch, 10" Opaque, 2 Side Flocking, With Filter 1 1/2"
• 10768455105653: SUR-FIT Natura® Drainable Pouch, 10" Opaque, 2 Side Flocking, With Filter 1 1/4"
• 10768455105646: SUR-FIT Natura® Drainable Pouch, 12" Transparent, 1 Side Flocking, With Filter 2 3/4"
• 10768455105639: SUR-FIT Natura® Drainable Pouch, 12" Transparent, 1 Side Flocking, With Filter 2 1/4"
• 10768455105622: SUR-FIT Natura® Drainable Pouch, 12" Transparent, 1 Side Flocking, With Filter1 3/4"
• 10768455105615: SUR-FIT Natura® Drainable Pouch, 12" Transparent, 1 Side Flocking, With Filter 1 1/2"
• 10768455104540: SUR-FIT Natura® Durahesive® Moldable Convex Skin Barrier With 57Mm.-(2 1/4" ) Flange, Mold -To
• 10768455104533: SUR-FIT Natura® Durahesive® Moldable Convex Skin Barrier With 45Mm.-(1 3/4" ) Flange, Mold -To
• 10768455104526: SUR-FIT Natura® Durahesive® Moldable Convex Skin Barrier With 45Mm.-(1 3/4" ) Flange, Mold -To
• 10768455104052: Visi-Flow® Irrigation Adapter Faceplate 1 3/4"
• 10768455103505: SUR-FIT Natura® Urostomy Pouch Bend, Trans. Std. W/1-Sided Comfort Panel, 1 1/4"
• 10768455143846: Natura® Convex Accordion Flange Ctf, Durahesive Skin Barrier W/Hydrocolloid, 70Mm, 2 3/4"
• 10768455143822: Natura® Convex Accordion Flange Ctf, Durahesive Skin Barrier W/Acrylic Collar, 70Mm, 2 3/4"
• 10768455143808: Natura® Convex Accordion Flange Ctf, Durahesive Skin Barrier W/Hydrocolloid, 57Mm, 2 1/4"
• 10768455143785: Natura® Convex Accordion Flange Ctf, Durahesive Skin Barrier W/Acrylic Collar, 57Mm, 2 1/4"
• 10768455143761: Natura® Convex Accordion Flange Ctf, Durahesive Skin Barrier W/Hydrocolloid, 45Mm, 1 3/4"
• 10768455143747: Natura® Convex Accordion Flange Ctf, Durahesive Skin Barrier W/Acrylic Collar, 45Mm, 1 3/4"
• 10768455138460: Natura® Stomahesive® Cut-To-Fit, Accordion Flange 70Mm, 2 3/4"
• 10768455138422: Natura® Durahesive® Cut-To-Fit, Accordion Flange 70Mm, 2 3/4"
• 10768455138385: Natura® Stomahesive® Cut-To-Fit, Accordion Flange 57Mm, 2 1/4"
• 10768455138347: Natura® Durahesive® Cut-To-Fit, Accordion Flange 57Mm, 2 1/4"
• 10768455138309: Natura® Stomahesive® Cut-To-Fit, Accordion Flange 45Mm, 1 3/4"
• 10768455138262: Natura® Durahesive® Cut-To-Fit, Accordion Flange 45Mm, 1 3/4"
• 10768455127600: Natura® High Output Pouch Transparent W/1-Sided Comfort Panel W/ Filter 2 3/4"
• 10768455127594: Natura® High Output Pouch Transparent W/1-Sided Comfort Panel W/ Filter 2 1/4"
• 10768455127587: Natura® High Output Pouch Transparent W/1-Sided Comfort Panel W/ Filter 1 3/4"
• 10768455115966: Post Op Kit: Natura® Two-Piece, Drainable, 2 3/4" (70Mm), Transparent, Standard, With Invisiclo
• 10768455105981: SUR-FIT Natura® Moldable Durahesive® Skin Barrier With Hydrocolloid Flexible Collar [57Mm (2 1
• 10768455105677: SUR-FIT Natura® Drainable Pouch, 10" Opaque, 2 Side Flocking, With Filter 1 3/4"
• 10768455104069: Visi-Flow® Irrigation Adapter Faceplate 2 3/4"