FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00846430005488
·
Model: ER3C-300
·
ETYMOTIC RESEARCH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 00846430005488
- Version / Model
- ER3C-300
- Company Name
- ETYMOTIC RESEARCH, INC.
- Labeler DUNS
- 115380859
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-04
- Public Version
- 3
- Public Version Date
- 2025-06-30
- Public Version Status
- Update
- Public Device Record Key
- 4d7412ae-fa50-4ff6-925f-1963a38de03a
Device Description
ER3C-300 System consists of the following items: ER3C-300 Audiometric Insert Earphones, ER3C-84 7' cable with dual-mono 6.33 mm (1/4") plugs or ER3-19 Cable Shielded 300 Ohm 16' (ABR) or ER3-31 Shielded (ABR) Cable, or ER3-32 Shielded (ABR) Cable, ER3C-14A foam eartips (regular, 13 mm), ER3C-14B foam eartips (small, 10 mm), ER3C-14C foam eartips (large, 18 mm)
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
- 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 |
|---|---|---|---|---|
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62133 | Audiometric ear tip | A luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00846430005488 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930003 | 000 |