| Primary Device ID | 00850013007387 |
| NIH Device Record Key | 7d8226f1-d5f9-4763-865f-c689599fb302 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Impression Dispenser |
| Version Model Number | IDG01 |
| Catalog Number | IDG01 |
| Company DUNS | 611658795 |
| Company Name | EARLENS CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850013007387 [Primary] |
| LDG | Kit, Earmold, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2023-06-09 |
| 08500130070192 - Earlens ELF USB | 2023-11-03 Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot n |
| 00850013007387 - Impression Dispenser | 2023-06-19 |
| 00850013007387 - Impression Dispenser | 2023-06-19 |
| 00850013007516 - Earlens Processor, Champagne | 2023-06-19 |
| 00850013007523 - Earlens Processor, Silver | 2023-06-19 |
| 00850013007530 - Earlens Processor, Black | 2023-06-19 |
| 00850013007547 - Earlens Ear Tip, Left | 2023-06-19 |
| 00850013007554 - Earlens Ear Tip, Right | 2023-06-19 |
| 00850013007561 - Earlens Tympanic Lens, Left | 2023-06-19 |