Unitron
- Primary DI
- 00698764550550
- Brand
- Unitron
- Company
- Unitron Hearing Ltd
- Model
- 050-5857-43
- Catalog number
- 050-5857-43
- Device description
- Quantum2 Pro HP (metallic dark gray)
- Published
- 2016-09-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| OSM | Hearing aid, air conduction with wireless technology |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00698764550550 | Primary | GS1 | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Behind-the-ear air-conduction hearing aid | A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1 519 895 0100 | Quality@unitron.com |
Regulatory Flags
- DUNS number
- 201252087
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07630034362732 | UNITRON | 063-6001-01 | 063-6001-01 | 2018-02-28 |
| 07630034362749 | UNITRON | 063-6002-01 | 063-6002-01 | 2018-02-28 |
| 07630034362756 | UNITRON | 063-6003-01 | 063-6003-01 | 2018-02-28 |
| 07630034362763 | UNITRON | 063-6004-01 | 063-6004-01 | 2018-02-28 |
| 07630034362770 | UNITRON | 063-6005-01 | 063-6005-01 | 2018-02-28 |
| 07630034362787 | UNITRON | 063-6006-01 | 063-6006-01 | 2018-02-28 |
| 07630034362794 | UNITRON | 063-6007-01 | 063-6007-01 | 2018-02-28 |
| 07630034362824 | UNITRON | 063-6008-01 | 063-6008-01 | 2018-02-28 |
| 07630034362831 | UNITRON | 063-6009-01 | 063-6009-01 | 2018-02-28 |
| 07630034362848 | UNITRON | 063-6010-01 | 063-6010-01 | 2018-02-28 |
| 07630034362855 | UNITRON | 063-6011-01 | 063-6011-01 | 2018-02-28 |
| 07630034362886 | UNITRON | 063-6012-01 | 063-6012-01 | 2018-02-28 |
| 07630034362893 | UNITRON | 063-6013-01 | 063-6013-01 | 2018-02-28 |
| 07630034362947 | UNITRON | 063-6014-01 | 063-6014-01 | 2018-02-28 |
| 07630034362961 | UNITRON | 063-6015-01 | 063-6015-01 | 2018-02-28 |
| 07630034362978 | UNITRON | 063-6016-01 | 063-6016-01 | 2018-02-28 |
| 07630034362985 | UNITRON | 063-6017-01 | 063-6017-01 | 2018-02-28 |
| 07630034362992 | UNITRON | 063-6018-01 | 063-6018-01 | 2018-02-28 |
| 07630034363005 | UNITRON | 063-6019-01 | 063-6019-01 | 2018-02-28 |
| 07630034363029 | UNITRON | 063-6020-01 | 063-6020-01 | 2018-02-28 |
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