FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FREEDOM COIL MAGNET, BEIGE, 2M
DI: 09321502029414
·
Model: S18122
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FREEDOM COIL MAGNET, BEIGE, 2M
- Primary DI
- 09321502029414
- Version / Model
- S18122
- Catalog Number
- S18122
- 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
- 6
- Public Version Date
- 2023-07-28
- Public Version Status
- Update
- Public Device Record Key
- 48044809-204e-4bb6-b48c-809c7a9c8a09
- Distribution End Date
- 2019-11-14
Device Description
FREEDOM COIL MAGNET, BEIGE, 2M
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
- No
- 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 | 09321502029414 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P970051 | 028 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 2M strength magnet |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity