FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 09120041050367
·
Model: NIKOLAI-57/20/GO
·
BHM-Tech Produktionsgesellschaft m.b.H.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 09120041050367
- Version / Model
- NIKOLAI-57/20/GO
- Catalog Number
- 77733167
- Company Name
- BHM-Tech Produktionsgesellschaft m.b.H.
- Labeler DUNS
- 300632705
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2020-04-06
- Public Version Status
- Update
- Public Device Record Key
- f027e265-8784-45ae-8bc0-adea7596ffed
Device Description
spectacles front; AN-Evo1; contact star evo1
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
- 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 |
|---|---|---|---|---|
| 47286 | Head-worn bone-conduction hearing aid | An electrically-powered acoustic device intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear. It typically consists of a microphone, amplifier, and vibrator mounted or magnetically connected to a headband, spectacles or an implantable magnet; it may include positioning and protection devices. The microphone receives sound waves and converts them into electrical signals sent to the vibrator which transmits vibrations, typically through the mastoid bone, to the inner ears for hearing. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09120041050367 | GS1 |
Customer Contacts
- Phone
- +43335920078
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121793 | 000 |