Catalog Number

-

Brand Name

Burkhart Syringe Sleeve W/Opening (500)

Version/Model Number

72720376

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

-

Product Code

MMP

Product Code Name

Cover, Barrier, Protective

Public Device Record Key

294ef3d2-89cc-44d2-b767-db97121c50a2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

10854212006728

Quantity per Package

24

Contains DI Package

00854212006721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-