FDA UDI
In Commercial Distribution
🇺🇸 United States
Osia® 2 Sound Processor Tool Kit
DI: 09321502045124
·
Model: Osia 2 System
·
COCHLEAR LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Osia® 2 Sound Processor Tool Kit
- Primary DI
- 09321502045124
- Version / Model
- Osia 2 System
- Catalog Number
- P1343785
- Company Name
- COCHLEAR LIMITED
- Labeler DUNS
- 750551194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-05
- Public Version
- 1
- Public Version Date
- 2020-09-14
- Public Version Status
- New
- Public Device Record Key
- b443735a-0b6c-468c-9dfe-4f263cb55cd5
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PFO | Active implantable bone conduction hearing system | Ear, Nose, Throat | 874.3340 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64987 | Hearing implant system sound processor activation kit | A collection of non-powered devices intended to be used by a healthcare professional in a clinical setting to assist with the activation/programming of a hearing implant system sound processor (not included). It typically includes a battery cover opener/closer, magnet inserter/remover, and temporary cover intended to protect the sound processor from environmental exposure during its connection to an external device (e.g., computer) for adjustment of settings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502045124 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191921 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature