Mara Console GEN-16-050

GUDID 00857379006023

The Mara Console guides the physician through the procedure by use of a graphical user interface; regulates the creation of water vapor in the Water Vapor Probe; and provides automated real-time monitoring and active management throughout the procedure.

AEGEA MEDICAL INC.

Circulating-fluid endometrial-ablation catheter Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit Water vapour endometrial-ablation control unit

• Primary Device ID: 00857379006023
• NIH Device Record Key: 56ec49c7-f44d-47bd-9815-670a36bfdb3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mara Console
• Version Model Number: GEN-16-050
• Catalog Number: GEN-16-050
• Company DUNS: 825284834
• Company Name: AEGEA MEDICAL INC.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com
• Phone: 6507011125
• Email: tkelly@aegeamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857379006023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160047

FDA Product Code

• MNB: Device, Thermal Ablation, Endometrial

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: 2020-03-24
• Device Publish Date: 2020-03-16

Devices Manufactured by AEGEA MEDICAL INC.

• 00857379006023 - Mara Console: 2020-03-24The Mara Console guides the physician through the procedure by use of a graphical user interface; regulates the creation of water vapor in the Water Vapor Probe; and provides automated real-time monitoring and active management throughout the procedure.
• 00857379006023 - Mara Console: 2020-03-24 The Mara Console guides the physician through the procedure by use of a graphical user interface; regulates the creation of wate
• 00857379006030 - Mara Water Vapor Probe Kit: 2020-03-24 Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe and saline s