Catalog Number

-

Brand Name

20 gauge flow thru tips (25pack)

Version/Model Number

90090

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2022

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

KXR

Product Code Name

Applicator, Resin

Public Device Record Key

eb3d0c30-67f8-4de3-a585-51c9e54ecd22

Public Version Date

October 07, 2022

Public Version Number

2

DI Record Publish Date

September 01, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-