FDA UDI
In Commercial Distribution
🇺🇸 United States
Mi1200 SYNCHRONY PIN +FLEX24
DI: 09008737094010
·
Model: 09401
·
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Mi1200 SYNCHRONY PIN +FLEX24
- Primary DI
- 09008737094010
- Version / Model
- 09401
- Company Name
- Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
- Labeler DUNS
- 300764032
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-02-28
- Public Version
- 5
- Public Version Date
- 2022-09-14
- Public Version Status
- Update
- Public Device Record Key
- 73739ce3-adc0-4476-975d-e9b335220e95
Device Description
Cochlear Implant
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MCM | IMPLANT, COCHLEAR | Unknown | 3 | |
| PGQ | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47373 | Cochlear implant system electrode array assembly | The implantable portion of a cochlear implant system [cochlear implant (CI)] that typically consists of an electrically-powered electrode array surgically implanted in one cochlea, and a receiver-stimulator implanted in the skull near the ear and connected to the electrode array; it does not elute a drug. Electrical signals are transmitted from the external portion of the device to the receiver-stimulator and ultimately to the cochlea, via the electrode array, for the partial restoration of auditory sensation in a severely/profoundly deaf person. Dedicated implantation instruments may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09008737094010 | GS1 |
Customer Contacts
- Phone
- +1(888)633-3524
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000025 | 079 |
| P000025 | 084 |
| P000025 | 090 |
| P000025 | 122 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 131 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius