Identity
- Trade Name
- Mara Console FDA UDI
- Generic Name
- Water vapour endometrial-ablation control unit FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- GEN-16-050 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- GEN-16-050 FDA UDI
- Primary DI / UDI-DI
- 00857379006023 FDA UDI
- PMA Number
- P160047 FDA UDI
- FDA Product Code
- MNB FDA UDI
- GMDN Term
- Water vapour endometrial-ablation control unit FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Water vapour endometrial-ablation control unit
Mara Console by Aegea Medical Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Water vapour endometrial-ablation control unit.
- Mara Console — CooperSurgical, Inc. · Class III
Cleared under the same submission
P160047 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aegea Medical Inc.
Sources (1)
- FDA UDI 56ec49c7-f44d-47bd-9815-670a36bfdb3e 36 fields · synced Jun 8, 2026