FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Nucleus CP900 Series Magnet
DI: 09321502023252
·
Model: Z285923
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nucleus CP900 Series Magnet
- Primary DI
- 09321502023252
- Version / Model
- Z285923
- Catalog Number
- Z285923
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 4
- Public Version Date
- 2023-07-27
- Public Version Status
- Update
- Public Device Record Key
- 681af43f-17d5-4990-911f-789cb74a1fb2
- Distribution End Date
- 2023-03-31
Device Description
Strength: 5M Color: Mocha (brown)
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 |
|---|---|---|---|---|
| 62944 | Hearing implant system external magnet | A small, magnetic device intended to hold in place the sound processor and/or coil (not included) of a hearing implant system (e.g., cochlear, auditory brainstem, bone-conduction, partially-implantable middle ear implant system), to the outside of the scalp, typically by coupling with an implanted magnet. It is typically a magnetized metal disc that is attached to the processor/coil, but may be supplied separately. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502023252 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970051 | 096 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5 M strength magnet |