FDA UDI
In Commercial Distribution
🇺🇸 United States
Ceretone
DI: 00860010331095
·
Model: Core one
·
Audicon Corporation
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Ceretone
- Primary DI
- 00860010331095
- Version / Model
- Core one
- Company Name
- Audicon Corporation
- Labeler DUNS
- 118836847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-29
- Public Version
- 2
- Public Version Date
- 2025-09-12
- Public Version Status
- Update
- Public Device Record Key
- 8688f930-d230-4c10-a808-a5ed488beeb2
Device Description
OTC Hearing Aid
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| QUF | Hearing Aid, Air-Conduction, Over The Counter | Ear, Nose, Throat | 874.3300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34672 | Air-conduction hearing aid, in-the-ear | 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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20860010331099 | GS1 | Case | 40 | In Commercial Distribution | |
| Primary | 00860010331095 | GS1 | ||||
| Package | 10860010331092 | GS1 | Inner Pack | 2 | In Commercial Distribution | |
| Package | 30860010331096 | GS1 | Csae | 20 | In Commercial Distribution | |
| Package | 40860010331093 | GS1 | Pallet | 495 | In Commercial Distribution |