SUR-FIT NATURA

Basic Information

• Brand Name: SUR-FIT NATURA
• Primary DI: 00768455116164
• Version / Model: 416945
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-03-29
• Public Version: 3
• Public Version Date: 2022-05-23
• Public Version Status: Update
• Public Device Record Key: 8c9b3d2f-3138-4d92-bc04-55264662c887
• Distribution End Date: 2022-05-20

Device Description

Post Op Kit: Natura Two-Piece Urostomy, 2 1/4 in, Transparent, Standard, with Accuseal Tap, with Stomahesive Cut-To-Fit Skin Barrier

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
FON	Bag, Drainage, With Adhesive, Ostomy	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	10768455116161	GS1	Case	6	Not in Commercial Distribution	2022-05-20
Primary	00768455116164	GS1
Unit of Use	80768455116160	GS1

Customer Contacts

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