Catalog Number

-

Brand Name

Bactisure™

Version/Model Number

00-8887-001-00

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

-

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

-

FDA Premarket Submission

K161165,K161165

Product Code

FQH

Product Code Name

Lavage, Jet

Public Device Record Key

369b323b-d421-4d6f-8f3b-806a0687892e

Public Version Date

May 19, 2020

Public Version Number

2

DI Record Publish Date

July 24, 2018

Package DI Number

10864076000206

Quantity per Package

6

Contains DI Package

00864076000209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-