FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Etymotic Research
DI: 00846430004597
·
Model: ER7-14C-EM
·
ETYMOTIC RESEARCH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Etymotic Research
- Primary DI
- 00846430004597
- Version / Model
- ER7-14C-EM
- Company Name
- ETYMOTIC RESEARCH, INC.
- Labeler DUNS
- 115380859
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 4
- Public Version Date
- 2023-11-17
- Public Version Status
- Update
- Public Device Record Key
- bb070c51-fc9a-4f72-8964-544e5d4f806b
- Distribution End Date
- 2016-10-11
Device Description
ER1-14A foam ear tips with ER7-14C probe tubes
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | Ear, Nose, Throat | 874.3310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45241 | Audiometric/hearing aid tester | An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing aid function when being fitted to the patient. It typically consists of a test box and a control unit that connect to an off-the-shelf computer that runs application software to provide results and graphics (which may be stored in a database). It may be used as an audiometer or real-ear-measurement instrument without the test box. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00846430004597 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K861113 | 000 |