Primary Device ID | 00850013007448 |
NIH Device Record Key | 160e7f28-b118-4b5a-876e-ae0a8357dfaa |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lateral Mixing Tip Kit |
Version Model Number | IDT05 |
Catalog Number | IDT05 |
Company DUNS | 611658795 |
Company Name | EARLENS CORPORATION |
Device Count | 7 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850013007448 [Unit of Use] |
GS1 | 00850013007509 [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 | 2021-12-13 |
Device Publish Date | 2021-12-03 |
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 |
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 |