FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Earlens Tympanic Lens
DI: 00850013007103
·
Model: TLEL1LR
·
EARLENS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Earlens Tympanic Lens
- Primary DI
- 00850013007103
- Version / Model
- TLEL1LR
- Catalog Number
- TLEL1LR
- 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
- 9
- Public Version Date
- 2021-09-09
- Public Version Status
- Update
- Public Device Record Key
- c28a838d-b46c-4801-818e-2a93fc0f9649
- Distribution End Date
- 2021-09-02
Device Description
Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this product box.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 62421 | Tympanic membrane contact hearing aid tympanic transducer | An electronic component of a tympanic membrane (TM) contact hearing aid intended to be placed in direct contact with the TM and to convert signals into vibrations, which are then passed along the normal sound conduction pathway in the middle ear. The TM transducer is non-surgically placed by a healthcare professional in a clinical setting and is intended to remain in situ indefinitely. The hearing aid is intended to compensate for mild/severe sensorineural impaired hearing by transmitting transduced sound waves, via light waves or an oscillating electromagnetic field, 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 | 00850013007103 | GS1 | ||||
| Unit of Use | 00850013007189 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 525 – 795 Millimeter of Mercury
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 525 – 795 Millimeter of Mercury
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius