FDA UDI
In Commercial Distribution
🇺🇸 United States
Cochlear
DI: 09321502046152
·
Model: P1170466
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cochlear
- Primary DI
- 09321502046152
- Version / Model
- P1170466
- Catalog Number
- P1170466
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-23
- Public Version
- 2
- Public Version Date
- 2025-03-07
- Public Version Status
- Update
- Public Device Record Key
- f8a5b227-2d0a-4d11-a882-972df4f8639d
Device Description
Cochlear Osia OSI200 Implant
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PFO | Active implantable bone conduction hearing system | Ear, Nose, Throat | 874.3340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64989 | Bone-conduction hearing implant system vibrator assembly | An electrically-powered, implantable device that typically consists of a radio-frequency (RF) antenna typically in the form of a coil, decoder, or vibrator coupled to the temporal bone, and a magnet. The antenna and decoder receive radio waves from the system’s external component and convert the signals back to audio frequencies, which are sent to the vibrator for the transmission of vibrations to the bone to activate the auditory pathway. The magnet is intended to couple with the system’s external component for positioning/stabilization of the system. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502046152 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191921 | 000 |