Catalog Number

DP5106K

Brand Name

ChemoPlus

Version/Model Number

DP5106K

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"

-

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

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

f1e3d384-1107-4fb9-946b-40800f43d229

Public Version Date

June 17, 2019

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

20884527004529

Quantity per Package

24

Contains DI Package

10884527004522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE