Catalog Number

-

Brand Name

Shamrock

Version/Model Number

10114

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)

Yes

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

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

ae40e68c-7aab-4a45-87f2-61f62857c92a

Public Version Date

May 18, 2021

Public Version Number

1

DI Record Publish Date

May 10, 2021

Package DI Number

10641932101143

Quantity per Package

10

Contains DI Package

00641932101146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE