SUR-FIT

Basic Information

• Brand Name: SUR-FIT
• Primary DI: 00768455107070
• Version / Model: 175650
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-09-28
• Public Version: 1
• Public Version Date: 2022-10-06
• Public Version Status: New
• Public Device Record Key: 6452ea00-b819-41fd-ac75-bf94b59fdd87

Device Description

Visi-Flow® Irrigation Sleeve Tail Closure

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZS	APPLIANCE, COLOSTOMY, DISPOSABLE	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37502	Ostomy bag closure device	A device intended to facilitate the emptying and/or reclosure of an open-ended ostomy bag. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10768455107077	GS1		12	In Commercial Distribution
Primary	00768455107070	GS1
Unit of Use	00768455181216	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]