FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Mara Console
DI: 00888937026870
·
Model: GEN-16-050
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Mara Console
- Primary DI
- 00888937026870
- Version / Model
- GEN-16-050
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-13
- Public Version
- 2
- Public Version Date
- 2026-04-02
- Public Version Status
- Update
- Public Device Record Key
- bbf8bd79-0dd9-4c5a-9112-3f73dde93e8f
- Distribution End Date
- 2025-12-31
Device Description
Mara Console- Endometrial Ablation
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 | 00888937026870 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160047 | 000 |