Catalog Number

1019-R

Brand Name

SANDEL

Version/Model Number

1019-R

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"

Yes

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

a3b53a54-ae65-420a-bdcd-eef2970739ac

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 25, 2022

Package DI Number

35414566830111

Quantity per Package

4

Contains DI Package

25414566830114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case