SUR-FIT NATURA

GUDID 10768455116017

Post OP Kit Sterile: Natura Two-Piece, Drainable, 4 in, Transparent, Standard, with Invisiclose Tail Closure, with Stomahesive Cut-To-Fit Skin Barrier

CONVATEC, PURCHASING DEPARTMENT

Multiple-piece intestinal ostomy bag, open-ended

• Primary Device ID: 10768455116017
• NIH Device Record Key: 8c87cbe8-0e01-4f2b-af6f-b5fda8a9a2ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUR-FIT NATURA
• Version Model Number: 416930
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• Email: cic@convatec.com
• Phone: 1-800-422-8811
• 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
• 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	00768455116010 [Primary]
GS1	00768455188895 [Unit of Use]
GS1	10768455116017 [Package]; Contains: 00768455116010; Package: Case [3 Units]; In Commercial Distribution
GS1	80768455116016 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811240

FDA Product Code

• EZP: Rod, Colostomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-03-22

On-Brand Devices [SUR-FIT NATURA]

• 10768455133274: Post Op Kit: Natura Durahesive Moldable Skin Barrier, Accordion Flange, Drainable, with Invisicl
• 10768455133267: Post Op Kit: Natura Durahesive Moldable Skin Barrier, Accordion Flange, Drainable, with Invisicl
• 10768455133250: Post Op Kit: Natura Durahesive Moldable Skin Barrier, Accordion Flange, Drainable, with Invisicl
• 10768455133243: Post Op Kit: Natura Stomahesive Moldable Skin Barrier, Accordion Flange, Drainable, with Invisic
• 10768455106711: SUR-FIT Natura Urostomy Pouch Bend, Transparent, Small with One Sided Comfort Panel, 1 1/4 in
• 10768455104243: SUR-FIT Natura Drainable Pouch, 12 in, Opaque with One Sided Comfort Panel, 2 3/4 in (70 mm)
• 10768455104229: SUR-FIT Natura Drainable Pouch, 12 in, Opaque with One Sided Comfort Panel, 2 1/4 in (57 mm)
• 10768455104212: SUR-FIT Natura Drainable Pouch, 12 in, Opaque with One Sided Comfort Panel, 1 3/4 in (45 mm)
• 10768455104205: SUR-FIT Natura Drainable Pouch, 12 in, Opaque with One Sided Comfort Panel, 1 1/2 in (38 mm)
• 10768455104199: SUR-FIT Natura Drainable Pouch, 12 in, Opaque with One Sided Comfort Panel, 1 1/4 in (32 mm)
• 10768455104137: SUR-FIT Natura Little Ones, Stomahesive, Flexible 4x4 in Skin Barrier, White Collar, 1 3/4 in
• 10768455104120: SUR-FIT Natura Little One, Stomahesive, Flexible 3x3 in Skin Barrier, White Collar 1 1/4 in
• 10768455103932: SUR-FIT Natura Durahesive, 6 x 6 in, Wafer with Flange, 4 in
• 10768455103796: SUR-FIT Natura Stomahesive, 5 x 5 in, Wafer with Flange, 2 3/4 in
• 10768455103765: SUR-FIT Natura Stomahesive, 4 x 4 in, wafer with Flange, 1 1/2 in
• 10768455103734: SUR-FIT Natura High Output Pouch Opaque with One Sided Comfort Panel with Filter, 2 1/4 in
• 10768455103727: SUR-FIT Natura High Output Pouch Opaque with One Sided Comfort Panel with Filter, 1 3/4 in
• 10768455103710: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Opaque, Standard with One Sided Comfort Panel,
• 10768455103703: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Opaque, Standard with One Sided Comfort Panel,
• 10768455103697: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Opaque, Standard with One Sided Comfort Panel,
• 10768455103680: SUR-FIR Natura Urostomy Pouch with Accuseal Tap, Opaque, Standard with One Sided Comfort Panel,
• 10768455103673: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Opaque, Standard with One sided Comfort Panel,
• 10768455103666: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Opaque, Small with One Sided Comfort Panel, 2 1
• 10768455103659: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Opaque, Small with One Sided Comfort Panel, 1 3
• 10768455103642: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Opaque, Small with One Sided Comfort Panel, 1 1
• 10768455103635: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Opaque, Small with One Sided Comfort Panel, 1 1
• 10768455103628: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Transparent, Standard with One Sided Comfort Pa
• 10768455103611: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Transparent, Standard with One Sided Comfort Pa
• 10768455103604: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Transparent, Standard with One Sided Comfort Pa
• 10768455103581: SUR-FIT Natura Urostomy Pouch with Accuseal Tap, Transparent, Standard, with One Sided Comfort P
• 10768455103574: SUR-FIT Natura Urostomy Pouch Bend, Transparent, Small with One Sided Comfort Panel, 2 1/4 in
• 10768455103567: SUR-FIT Natura Urostomy Pouch Bend, Transparent, Small with One Sided Comfort Panel, 1 3/4 in
• 10768455103550: SUR-FIT Natura Urostomy Pouch Bend, Transparent, Small with One Sided Comfort Panel, 1 1/2 in
• 10768455103543: SUR-FIT Natura Urostomy Pouch Bend, Transparent, Standard with One Sided Comfort Panel, 2 3/4 in
• 10768455103536: SUR-FIT Natura Urostomy Pouch Bend, Transparent, Standard with One Sided Comfort Panel, 2 1/4 in
• 10768455103529: SUR-FIT Natura Urostomy Pouch Bend, Transparent, Standard with One Sided Comfort Panel, 1 3/4 in
• 10768455103512: SUR-FIT Natura Urostomy Pouch Bend, Transparent, Standard with One Sided Comfort Panel, 1 1/2 in
• 10768455103499: SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 2 1/4 in
• 10768455103482: SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 3/4 in
• 10768455103475: SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 1/2 in
• 10768455103468: SUR-FIT Natura Mini Pouch, Opaque with One Sided Comfort Panel, 1 1/4 in
• 10768455103451: SUR-FIT Natura Closed-End Pouch, with Filter, Opaque with Two Sided Comfort Panel, 2 3/4 in
• 10768455103444: SUR-FIT Natura Closed-End Pouch with Filter, Opaque with Two Sided Comfort Panel, 2 1/4 in
• 10768455103420: SUR-FIT Natura Closed-End Pouch with Filter, Opaque with Two Sided Comfort Panel, 1 1/2 in
• 10768455103413: SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 2 3/4 in
• 10768455103406: SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 2 1/4 in
• 10768455103390: SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 1 3/4 in
• 10768455103383: SUR-FIT Natura Closed-End Pouch, Opaque with Two Sided Comfort Panel, 1 1/2 in
• 10768455103376: SUR-FIT Natura Drainable Pouch, 14 in, Transparent with One Sided Comfort Panel, 4 in
• 10768455103369: SUR-FIT Natura Drainable Pouch, 12 in, Transparent with One Sided Comfort Panel, 2 3/4 in