FDA UDI
Not in Commercial Distribution
🇺🇸 United States
MAESTRO 6.0
DI: 09008737318628
·
Model: 31862
·
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MAESTRO 6.0
- Primary DI
- 09008737318628
- Version / Model
- 31862
- Company Name
- Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Labeler DUNS
- 300764032
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-02-28
- Public Version
- 9
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 15c762e5-d597-4f3b-921c-f534f6910b64
- Distribution End Date
- 2021-01-26
Device Description
Fitting Software
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MCM | IMPLANT, COCHLEAR | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60211 | Audiometric/hearing device software | A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09008737318628 | GS1 |
Customer Contacts
- Phone
- +1(888)633-3524
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000025 | 078 |
| P000025 | 084 |
| P000025 | 092 |
| P000025 | 100 |
| P000025 | 115 |