Catalog Number

-

Brand Name

Get-A-Grip

Version/Model Number

79750PF-BKGR

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

K220373,K220373,K220373,K220373

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

c99b09e4-3fe3-4776-95a1-a6cd035f1d04

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Package DI Number

00150042054186

Quantity per Package

900

Contains DI Package

00850042054185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX