SUR-FIT NATURA

Basic Information

• Brand Name: SUR-FIT NATURA
• Primary DI: 00768455103706
• Version / Model: 401554
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-12-07
• Public Version: 3
• Public Version Date: 2022-10-27
• Public Version Status: Update
• Public Device Record Key: ea6b4193-050e-4973-9ffc-d5c84c2fbf5d

Device Description

SUR-FIT Natura® Urostomy Pouch With Accuseal® Tap, Opaque Standard, W/1-Sided Comfort Panel, 2 1/4"

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
EXH	BAG, URINARY, ILEOSTOMY	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31069	Multiple-piece urostomy bag, open-ended	A plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/changed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10768455103703	GS1	Case	24	In Commercial Distribution
Primary	00768455103706	GS1
Unit of Use	00768455182909	GS1

Customer Contacts

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