CNTRL+ Bladder Support Pessary PES-0006

GUDID 00990312419952

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 #00990312419945), Medium (GS1 #00990312419969), Large (GS1 #00990312419990). Each device is sold individually as well.

Cntrl+ Inc.

Bladder-supporting pessary

• Primary Device ID: 00990312419952
• NIH Device Record Key: caab9fd2-d092-4de2-bfd1-a2c3c9415854
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CNTRL+ Bladder Support Pessary
• Version Model Number: Starter Kit (S, M, L)
• Catalog Number: PES-0006
• Company DUNS: 204238856
• Company Name: Cntrl+ Inc.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1(855)268-7575
• Email: support@cntrlplus.com
• Phone: 1(855)268-7575
• Email: support@cntrlplus.com
• Phone: 1(855)268-7575
• Email: support@cntrlplus.com

Device Dimensions

• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00990312419952 [Primary]
GS1	00999999999993 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240798

FDA Product Code

• HHW: Pessary, Vaginal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-01
• Device Publish Date: 2025-08-22

On-Brand Devices [CNTRL+ Bladder Support Pessary]

• 00990312419990: The Cntrl+ Bladder Support Pessary is intended for the use in adult women, over 18 years of age
• 00990312419969: The Cntrl+ Bladder Support Pessary is intended for the use in adult women, over 18 years of age
• 00990312419952: The Cntrl+ Bladder Support Pessary is intended for the use in adult women, over 18 years of age
• 00990312419945: The Cntrl+ Bladder Support Pessary is intended for the use in adult women, over 18 years of age