SureFit Z

Basic Information

• Brand Name: SureFit Z
• Primary DI: 00852598007233
• Version / Model: Constriction Ring
• Company Name: AUGUSTA MEDICAL SYSTEMS, L.L.C.
• Labeler DUNS: 052255606
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-17
• Public Version: 3
• Public Version Date: 2021-07-01
• Public Version Status: Update
• Public Device Record Key: e2208c7a-6e96-4708-9adf-39ffd2e545d5

Device Description

Constriction Ring/Penile Ring

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	876.5020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46334	Penile ring	A device intended to be applied externally to the penis for the management of erectile dysfunction (ED) (commonly known as impotence) by enabling the maintenance of a penile erection adequate for vaginal intercourse. It is typically designed as a flexible rubber loop that is placed on the penis (i.e., around its base) to restrict the flow of venous blood leaving the penis during an erection. This device can be used alone or with a penile vacuum pump. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852598007233	GS1

Customer Contacts

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