FDA UDI
In Commercial Distribution
🇺🇸 United States
SONNET Rechargeable Battery Standard Pro
DI: 09008737461645
·
Model: 46164
·
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
- SONNET Rechargeable Battery Standard Pro
- Primary DI
- 09008737461645
- Version / Model
- 46164
- 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
- 2026-02-26
- Public Version
- 2
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- a456a138-f834-477e-a4f3-3cf3583fe83a
Device Description
Audio Processor Rechargeable Battery Pack
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| MCM | Implant, Cochlear | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58185 | Cochlear implant/auditory brainstem implant external battery | An external component of a cochlear implant (CI) or auditory brainstem implant system designed to supply direct current (DC) to operate the electrically-powered and dependent components of the system. It is typically worn behind-the-ear (BTE), or is neck- or waist-worn, and may include an on/off switch. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09008737461645 | GS1 |
Customer Contacts
- Phone
- 1-888-633-3524
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -29 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20.2 – 140 Degrees Fahrenheit