Catalog Number

X-80486B

Brand Name

Mixing Spatular 72ea Package

Version/Model Number

X-80486B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2021

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

a5d0c5c5-3edc-483b-a9b1-ba8f73124f5d

Public Version Date

March 15, 2021

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

-