FDA UDI
In Commercial Distribution
🇺🇸 United States
Osia OSI300 Implant
DI: 09321502070676
·
Model: P1772248
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Osia OSI300 Implant
- Primary DI
- 09321502070676
- Version / Model
- P1772248
- Catalog Number
- P1772248
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-15
- Public Version
- 1
- Public Version Date
- 2023-09-25
- Public Version Status
- New
- Public Device Record Key
- ff4cee11-868f-44c9-90b7-3398a28457f9
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 |
|---|---|---|---|---|
| 61176 | Implantable vibrator bone-conduction hearing implant system | A battery-powered, electromechanical device assembly intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear via an implanted vibrator. It typically consists of an externally worn microphone/sound processor, and a sterile vibrator assembly which is implanted in the skull (e.g., mastoid or temporal bone). The microphone receives sound waves and converts them into electrical signals (radio waves) which are sent to the vibrator wirelessly through the skin (transcutaneously) for the transmission of vibrations to the inner ear via bone conduction. It is used to treat conductive and mixed hearing loss. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502070676 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231204 | 000 |