FDA UDI
In Commercial Distribution
🇺🇸 United States
3000 Real Ear
DI: 05711781004143
·
Model: BC1 Bone Conductor
·
Auditdata A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 3000 Real Ear
- Primary DI
- 05711781004143
- Version / Model
- BC1 Bone Conductor
- Catalog Number
- 100.060
- Company Name
- Auditdata A/S
- Labeler DUNS
- 310385849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-23
- Public Version
- 1
- Public Version Date
- 2026-02-02
- Public Version Status
- New
- Public Device Record Key
- 6f7b370c-26cd-4082-9856-c33cfb6367bb
Device Description
BC1 Bone Conductor (2000-1)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35619 | Auditory cranial bone vibrator | An electromechanical transducer intended to produce the sensation of hearing by vibrating the cranial bones. It can be used as an output device with an audiometer to measure bone-conduction hearing thresholds, and thus serve as an adjunct to air-conduction testing with conventional earphones. Comparison of the results enables the clinician to distinguish hearing loss attributable to the external or middle ear (conductive loss) from the inner ear (sensory loss). In addition, this device may be used to provide output for a hearing aid for patients who cannot wear an earmould. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05711781004143 | GS1 |