Primary Device ID | 00714646000804 |
NIH Device Record Key | b12e2884-eb0b-47f2-8d7c-28e19af1808b |
Commercial Distribution Discontinuation | 2024-01-03 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | AlphaCleanse® Antimicrobial Wound Care System |
Version Model Number | WI-5750 |
Catalog Number | 5750 |
Company DUNS | 117844489 |
Company Name | Bionix, LLC |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
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 | true |
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 | |
Phone | +1(800)551-7096 |
Bionix@Bionix.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00714646000804 [Primary] |
FQH | LAVAGE, JET |
Steralize Prior To Use | true |
Device Is Sterile | true |
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
[00714646000804]
Radiation Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2024-01-08 |
Device Publish Date | 2021-11-18 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ALPHACLEANSE 90546897 not registered Live/Pending |
Bionix, LLC 2021-02-25 |
![]() ALPHACLEANSE 90494662 not registered Live/Pending |
Bionix Development Corporation 2021-01-28 |