FDA UDI
In Commercial Distribution
🇺🇸 United States
Nucleus
DI: 09321502019859
·
Model: Z246024
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Nucleus
- Primary DI
- 09321502019859
- Version / Model
- Z246024
- Catalog Number
- Z246024
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 6
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- 2129a590-5d15-46a7-938d-62f44a9ecca1
Device Description
Cochlear Nucleus CP800 Series Litewear Cable (50cm, White)
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| 35643 | Cochlear implant system, external-microphone | A battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a severely/profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Implantation instruments may be packaged with the system. | Yes | Active |
| 61245 | Cochlear implant/auditory brainstem implant peripheral connector | A device designed to be used with a cochlear implant (CI) or auditory brainstem implant system to connect the sound processor to power options (e.g., battery pack) and/or to enable connections to external devices that may be used as peripherals to the implant system; the connected devices are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502019859 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970051 | 049 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 30 cm long cable | ||
| Length | 50 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity