Catalog Number

-

Brand Name

AlphaCleanse™ Antimicrobial Wound Care System

Version/Model Number

WI-05750

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FQH

Product Code Name

LAVAGE, JET

Public Device Record Key

b12e2884-eb0b-47f2-8d7c-28e19af1808b

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

November 18, 2021

Package DI Number

10714646000801

Quantity per Package

12

Contains DI Package

00714646000804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE