FDA UDI
In Commercial Distribution
🇺🇸 United States
Lucid Audio
DI: 00846430005679
·
Model: Lucid Hearing Travel #20056
·
ETYMOTIC RESEARCH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lucid Audio
- Primary DI
- 00846430005679
- Version / Model
- Lucid Hearing Travel #20056
- Company Name
- ETYMOTIC RESEARCH, INC.
- Labeler DUNS
- 115380859
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-20
- Public Version
- 1
- Public Version Date
- 2024-02-28
- Public Version Status
- New
- Public Device Record Key
- 324fbe8f-722c-4b9d-a709-0ebb87087644
Device Description
Lucid Hearing Travel Hearing Protection #20056
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EWD | Protector, Hearing (Insert) | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41230 | Earplugs, reusable | A device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00846430005679 | GS1 |
Customer Contacts
- Phone
- 1-866-202-2527
- [email protected]