FDA UDI
In Commercial Distribution
🇺🇸 United States
Cochlear
DI: 09321502046480
·
Model: P1624190
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- Cochlear
- Primary DI
- 09321502046480
- Version / Model
- P1624190
- Catalog Number
- P1624190
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2020-01-03
- Public Version
- 2
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- 5eee85e8-6ac3-4f86-9f54-e8e52abd8be5
Device Description
CP1000 5 (I) MAGNET COVER (SAND), PACKED
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 61381 | Cochlear implant/auditory brainstem implant sound processor/coil decorative cover | A device intended to be used as an aesthetic (decorative) cover for the sound processor and/or coil (not included) of a cochlear implant (CI) or auditory brainstem implant system. It is typically made of plastic material (e.g., polystyrene) designed to be clipped onto the sound processor/coil; it is available in a variety of colours/designs. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502046480 | GS1 | ||||
| Unit of Use | 09321502051019 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]