Catalog Number

1SPATULA

Brand Name

Spatula

Version/Model Number

1SPATULA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

05d610da-9501-4dcb-8bcb-adbfda2dbf0a

Public Version Date

August 21, 2019

Public Version Number

6

DI Record Publish Date

September 22, 2016

Package DI Number

D7981STAPULA1

Quantity per Package

50

Contains DI Package

D7981SPATULA0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag