FDA UDI
In Commercial Distribution
🇺🇸 United States
Mara Console
DI: 00857379006023
·
Model: GEN-16-050
·
AEGEA MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mara Console
- Primary DI
- 00857379006023
- Version / Model
- GEN-16-050
- Catalog Number
- GEN-16-050
- Company Name
- AEGEA MEDICAL INC.
- Labeler DUNS
- 825284834
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-16
- Public Version
- 3
- Public Version Date
- 2020-07-30
- Public Version Status
- Update
- Public Device Record Key
- 56ec49c7-f44d-47bd-9815-670a36bfdb3e
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MNB | Device, Thermal Ablation, Endometrial | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64808 | Water vapour endometrial-ablation control unit | An electrically-powered device designed to regulate the pressure and temperature of water for its vaporization and subsequent application, via an attached applicator (not included), to ablate the interior lining of the uterus (endometrium) to treat dysfunctional uterine bleeding (menorrhagia). It is typically a unit consisting of a digital user-interface [e.g., liquid-crystal display (LCD)] and treatment setting controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857379006023 | GS1 |
Customer Contacts
- Phone
- 6507011125
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160047 | 006 |