Catalog Number

-

Brand Name

Get-A-Grip

Version/Model Number

79760PF-RBGR

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

8b762046-3688-4b07-9477-571e9acb6d37

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

August 01, 2020

Package DI Number

10850020255563

Quantity per Package

1200

Contains DI Package

00850020255566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box