Catalog Number

X-80484B

Brand Name

5pcs Mixing Pad (Small) Pkg

Version/Model Number

X-80484B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 17, 2022

Issuing Agency

In HIBCC

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

8ca44db6-7222-4b78-af79-19fcb8da8dbe

Public Version Date

January 31, 2022

Public Version Number

2

DI Record Publish Date

November 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-