Catalog Number

31145918

Brand Name

Devon

Version/Model Number

31145918

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FZZ

Product Code Name

MARKER, SKIN

Public Device Record Key

746b14e2-8277-42b4-866c-a1425f5576d3

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 29, 2018

Package DI Number

10884527007530

Quantity per Package

25

Contains DI Package

10884521208759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK