Primary Device ID | 10714646000474 |
NIH Device Record Key | cc9a59c6-cdc7-44f0-b015-3967076deb8e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OtoClear Ear Irrigation System Wands |
Version Model Number | 27220 |
Catalog Number | 27220 |
Company DUNS | 117844489 |
Company Name | Bionix, LLC |
Device Count | 3 |
DM Exempt | true |
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 |
00714646001283 - Suture Removal Kit | 2025-03-20 Suture Removal Kit - 50ct case |
10714646001303 - ClearLook Lighted AngleLoop, Refill | 2025-03-05 ClearLook Lighted AngleLoop, 50ct Refill |
10714646001310 - ClearLook Lighted MicroLoop, Refill | 2025-03-05 ClearLook Lighted MicroLoop, 50ct Refill |
10714646001327 - ClearLook Lighted VersaLoop, Refill | 2025-03-05 ClearLook Lighted VersaLoop, 50ct Refill |
10714646001334 - ClearLook Lighted FlexLoop, Refill | 2025-03-05 ClearLook Lighted FlexLoop, 50ct Refill |
10714646001341 - ClearLook Lighted Variety Pack, Refill | 2025-03-05 ClearLook Lighted Variety Pack, 50ct Refill |
10714646001358 - ClearLook Lighted InfantScoop, Refill | 2025-03-05 ClearLook Lighted InfantScoop, 50ct Refill |
10714646001365 - ClearLook Lighted Variety Pack with Rechargeable Light Source | 2025-03-05 ClearLook Lighted Variety Pack with Rechargeable Light Source |