FDA UDI
In Commercial Distribution
🇺🇸 United States
Cochlear Nucleus CP800 Series Lapel Microphone
DI: 09321502018098
·
Model: Z208299
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cochlear Nucleus CP800 Series Lapel Microphone
- Primary DI
- 09321502018098
- Version / Model
- Z208299
- Catalog Number
- Z208299
- 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
- 2023-07-28
- Public Version Status
- Update
- Public Device Record Key
- 61228bb6-65a6-4ab2-9cd0-cf707760ae5c
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 |
|---|---|---|---|---|
| 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 | 09321502018098 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970051 | 049 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 150 | Centimeter | |
| Device Size Text, specify | 150 cm long cable |