Primary Device ID | 10714646000702 |
NIH Device Record Key | 71f86378-d94c-47d9-9a35-c66725babac0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OtoClear Ear Irrigation Tips |
Version Model Number | 7200ST |
Catalog Number | 7200ST |
Company DUNS | 117844489 |
Company Name | Bionix, LLC |
Device Count | 5000 |
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 | 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 |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com | |
Phone | +1(800)551-7096 |
Bionix@bionix.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00714646000705 [Primary] |
GS1 | 10714646000702 [Unit of Use] |
KCP | SYRINGE, ENT |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-31 |
Device Publish Date | 2023-07-21 |
10714646000542 - Lighted Ear Curette Demo Pack | 2024-07-18 Lighted Ear Curette Demo Pack |
00714646000552 - Sample, Lighted FlexLoop | 2024-07-18 Sample, Lighted FlexLoop |
10714646000566 - Sample, Safe Ear Curette Rainbow Pack | 2024-07-18 Sample, Safe Ear Curette Rainbow Pack |
10714646000641 - Lighted Ear Curette Demo Pack (monthly mailer) | 2024-07-18 Lighted Ear Curette Demo Pack (monthly mailer) |
00714646001085 - Sample, Lighted Suction Handle | 2024-07-18 Sample, Lighted Suction Handle |
00714646001252 - Lighted Articulating - Sample | 2024-06-24 Lighted Articulating Curette - Sample |
10714646001198 - SecureFoam | 2024-06-10 SecureFoam - Small |
10714646001204 - SecureFoam | 2024-06-10 SecureFoam - Medium |