FDA UDI
In Commercial Distribution
🇺🇸 United States
Baha 5 SuperPower Earhook 2+ (XS)
DI: 09321502051408
·
Model: P1173605
·
Cochlear Bone Anchored Solutions AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Baha 5 SuperPower Earhook 2+ (XS)
- Primary DI
- 09321502051408
- Version / Model
- P1173605
- Catalog Number
- P1173605
- Company Name
- Cochlear Bone Anchored Solutions AB
- Labeler DUNS
- 559784736
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-26
- Public Version
- 4
- Public Version Date
- 2025-01-27
- Public Version Status
- Update
- Public Device Record Key
- 02015a6e-d67b-49e1-b892-13bce63d323c
Device Description
Retention device to hold Baha 5 SuperPower sound processor in Under-the-Ear position (UTE)
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
- Yes
- 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 |
|---|---|---|---|---|
| LXB | Hearing aid, bone conduction | Ear, Nose, Throat | 874.3302 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58511 | Direct acoustic cochlear implant system | A battery-powered assembly of devices [direct acoustic cochlear implant (DACI)] intended to compensate for severe to profound mixed hearing loss by direct acoustical stimulation of the cochlea. It consists of an implanted receiver/stimulator (electronic assembly) connected to a transducer and a behind-the-ear (BTE) or at the head (button) sound processor consisting of a microphone(s), electronics, batteries, coil, and coil cable. The sound processor transmits an electric signal to the implant, via a radio-frequency link, where the signal is processed and passed to the transducer which converts the signal into vibrations that drive the perilymph inside the cochlea. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09321502051408 | GS1 |
Customer Contacts
- Phone
- +1(800)523-5798
- [email protected]