CNTRL+ Bladder Support Pessary

Basic Information

• Brand Name: CNTRL+ Bladder Support Pessary
• Primary DI: 00990312419952
• Version / Model: Starter Kit (S, M, L)
• Catalog Number: PES-0006
• Company Name: Cntrl+ Inc.
• Labeler DUNS: 204238856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2025-08-22
• Public Version: 3
• Public Version Date: 2026-03-16
• Public Version Status: Update
• Public Device Record Key: caab9fd2-d092-4de2-bfd1-a2c3c9415854

Device Description

The Cntrl+ Bladder Support Pessary is intended for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence). Starter Kit containing 3 devices: Small (GS1 #990312419945), Medium (GS1 #990312419969), Large (GS1 #990312419990). Each device is sold individually as well.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
59167	Bladder-supporting pessary	A non-sterile plastic device designed for insertion into the vagina to facilitate management of female urinary incontinence and/or to reduce bladder prolapse. Otherwise known as a bladder-neck support prosthesis, it is designed in the form of a ring with two prongs at one end. The ring is intended to be placed and held in the vagina with the prongs projecting forwards on each side of the urethral opening, thereby supporting the urethra/bladder neck/bladder. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00990312419952	GS1
Unit of Use	00999999999993	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K240798	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	37.7	Millimeter
Height	54.74	Millimeter
Outer Diameter	40.6	Millimeter
Height	60.54	Millimeter
Outer Diameter	45.2	Millimeter
Height	59.24	Millimeter