Primary Device ID | 00714646000989 |
NIH Device Record Key | 4be4c7b5-fe60-460b-bfa3-a32644325f1d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sample, OtoClear® Ear Irrigation System (220V) |
Version Model Number | SP-27247 |
Catalog Number | 27247 |
Company DUNS | 117844489 |
Company Name | Bionix, LLC |
Device Count | 1 |
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 | 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 | true |
OTC Over-The-Counter | false |
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