Catalog Number

-

Brand Name

Safe Plus

Version/Model Number

LGPF-04

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)

-

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

e8df95e8-74bd-4926-9b3e-ecab9751ebdd

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 24, 2020

Package DI Number

19555867100151

Quantity per Package

10

Contains DI Package

09555867100154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box