FDA UDI
In Commercial Distribution
🇺🇸 United States
Cochlear™ Magnet Reverse Polarity (3 M, Sand)
DI: 09321502037266
·
Model: P715045
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cochlear™ Magnet Reverse Polarity (3 M, Sand)
- Primary DI
- 09321502037266
- Version / Model
- P715045
- Catalog Number
- P715045
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-07
- Public Version
- 8
- Public Version Date
- 2024-05-03
- Public Version Status
- Update
- Public Device Record Key
- 379282ee-11e8-47e0-ab37-1c35b9191718
Device Description
3M Sand
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
- No
- 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, reusable | 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. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502037266 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970051 | 151 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3 M strength magnet |