| Primary Device ID | 08500130070253 |
| NIH Device Record Key | eb3aa179-f686-4409-b60f-016c1f65fe36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Earlens Tympanic Lens |
| Version Model Number | ITL01LR |
| Company DUNS | 611658795 |
| Company Name | EARLENS CORPORATION |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Handling Environment Atmospheric Pressure | Between 525 Millimeter of Mercury and 795 Millimeter of Mercury |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08500130070253 [Primary] |
| GS1 | 08500130070338 [Unit of Use] |
| PLK | Tympanic Membrane Direct Contact Hearing Aid |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-14 |
| Device Publish Date | 2019-05-06 |
| 08500130070253 | Inductive Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this |
| 08500130070246 | Inductive Tympanic Lens L- left, R - Right |
| 00850013007257 | Inductive Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this |
| 00850013007240 | Inductive Tympanic Lens L- left, R - Right |
| 00850013007103 | Tympanic Lens - 1 left and 1 right. Lenses are not individually packaged within this product bo |
| 00850013007097 | Tympanic Lens L- left, R - Right |