FDA UDI
In Commercial Distribution
🇺🇸 United States
Cochlear™ Baha® 6 Max Battery Door, 10 pcs
DI: 09321502053051
·
Model: P1668427
·
Cochlear Bone Anchored Solutions AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Cochlear™ Baha® 6 Max Battery Door, 10 pcs
- Primary DI
- 09321502053051
- Version / Model
- P1668427
- Catalog Number
- P1668427
- Company Name
- Cochlear Bone Anchored Solutions AB
- Labeler DUNS
- 559784736
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-02-25
- Public Version
- 1
- Public Version Date
- 2021-03-05
- Public Version Status
- New
- Public Device Record Key
- 6ff38a75-436b-4a6d-ba0d-4e40c93160d6
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 |
|---|---|---|---|---|
| LXB | Hearing aid, bone conduction | Ear, Nose, Throat | 874.3302 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62209 | Bone-conduction hearing implant system sound processor/vibrator | An electrically-powered, external device intended to compensate for impaired hearing by receiving sound waves from the environment and converting them into vibrations, which are transmitted to the inner ear via the temporal bone. It typically incorporates a microphone, transmitter/receiver and vibrator connected or magnetically coupled to vibrating implantable components (e.g., vibration transmission screw, partially-implantable abutment) for retention and transmission of vibrations to the inner ear; it may include positioning and protection devices. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 09321502062169 | GS1 | ||||
| Primary | 09321502053051 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202048 | 000 |