FDA UDI
In Commercial Distribution
🇺🇸 United States
Nucleus
DI: 09321502022545
·
Model: Z277519
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nucleus
- Primary DI
- 09321502022545
- Version / Model
- Z277519
- Catalog Number
- Z277519
- 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
- 4
- Public Version Date
- 2020-12-21
- Public Version Status
- Update
- Public Device Record Key
- ffbcfe4e-872a-4a77-9fae-5c2f2408cd75
Device Description
Cochlear Nucleus CR210 Remote Control
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
- Yes
- 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 |
|---|---|---|---|---|
| 57885 | Hearing aid/implant system remote control | A battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502022545 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970051 | 096 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity