Reia

GUDID 00860012119332

Size 1 Fitting Pessary

Reia, LLC

Pelvic-organ-supporting pessary

• Primary Device ID: 00860012119332
• NIH Device Record Key: 1bcbaee5-d912-43de-b74d-8e7fdc43adf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reia
• Version Model Number: FP01-1
• Company DUNS: 081063360
• Company Name: Reia, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012119332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232677

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: 2024-07-30
• Device Publish Date: 2024-07-22

On-Brand Devices [Reia]

• 00860012119387: Size 3 Applicator
• 00860012119370: Size 2 Applicator
• 00860012119363: Size 1 Applicator
• 00860012119356: Size 3 Fitting Pessary
• 00860012119349: Size 2 Fitting Pessary
• 00860012119332: Size 1 Fitting Pessary
• 00860012119325: Size 3 Patient Pessary
• 00860012119318: Size 2 Patient Pessary
• 00860012119301: Size 1 Patient Pessary
• 00860012119394: Fitting Pessary Kit