Uresta®

Basic Information

• Brand Name: Uresta®
• Primary DI: 00692379000264
• Version / Model: UR208
• Catalog Number: UR208
• Company Name: Resilia Inc
• Labeler DUNS: 202781183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2020-11-23
• Public Version: 3
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: 23b03377-b336-4844-a1c8-e9fe5d799817

Device Description

Uresta Bladder Support Starter Kit

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HHW	Pessary, Vaginal	Obstetrics/Gynecology	884.3575	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59082	Urinary-incontinence vaginal insert, reusable	A non-sterile, device intended to be inserted into the vagina in order to relieve mixed or stress urinary incontinence in an adult female by providing urethral support when pressure is transferred from the abdomen to the pelvic floor area (e.g. upon coughing, laughing, sneezing, exertion). It is a non-absorbent device with a removal cord; an application kit (tube and push rod) is typically included. This is a reusable device - after appropriate cleaning - intended for single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00692379000264	GS1
Unit of Use	00692379000257	GS1
Package	10692379000261	GS1		6	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083769	000