| Primary Device ID | 08500130070208 |
| NIH Device Record Key | dd20b4f2-254b-40df-a7f9-74d0e82b3a65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Earlens Processor |
| Version Model Number | IPR01XX |
| Company DUNS | 611658795 |
| Company Name | EARLENS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08500130070208 [Primary] |
| 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 |
| 08500130070208 | Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black |
| 00850013007202 | Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black |
| 00850013007011 | Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR-Bro |
| 00850013007462 | Inductive Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black |