FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Earlens Processor & Light Tip
DI: 08500130070086
·
Model: PLEL1LR
·
EARLENS CORPORATION
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Earlens Processor & Light Tip
- Primary DI
- 08500130070086
- Version / Model
- PLEL1LR
- Catalog Number
- PLEL1LR
- Company Name
- EARLENS CORPORATION
- Labeler DUNS
- 611658795
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 8
- Public Version Date
- 2019-03-28
- Public Version Status
- Update
- Public Device Record Key
- 27037f91-65d8-47f1-a6fa-1e10366c3b04
- Distribution End Date
- 2017-03-11
Device Description
Kit containing 1 left Processor & Lght Tip that are connected together and 1 right Processor & Lght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown
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
- 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 |
|---|---|---|---|---|
| PLK | Tympanic Membrane Direct Contact Hearing Aid | Ear, Nose, Throat | 874.3315 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62420 | Tympanic membrane contact hearing aid ear tip transmitter | An electronic component of a tympanic membrane (TM) contact hearing aid intended to be placed inthe external auditory canal to convert electrical signals from a sound processor into light signals orelectromagnetic energy for transmission to another component. The hearing aid is intended tocompensate for mild/severe sensorineural impaired hearing by transmitting transduced soundwaves, via light waves or an oscillating electromagnetic field, to a vibrator component in directcontact with the TM; it may include a custom-made earmould in which it is held in place. | No | Active |
| 62419 | Tympanic membrane contact hearing aid sound processor | An electronic component of a tympanic membrane (TM) contact hearing aid designed to be wornbehind-the-ear (BTE) and to receive sound waves and convert them into electrical signals fortransmission to another component. The hearing aid is intended to compensate for mild/severesensorineural impaired hearing by transmitting transduced sound waves, via light waves orelectromagnetic energy, to a vibrator component in direct contact with the TM. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08500130070086 | GS1 | ||||
| Unit of Use | 08500130070178 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 525 – 795 Millimeter of Mercury
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 525 – 795 Millimeter of Mercury