Catalog Number

DP5016K

Brand Name

ChemoPlus

Version/Model Number

DP5016K

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

ab1b4b15-e1c6-4b03-9189-820bf683c7d4

Public Version Date

June 17, 2019

Public Version Number

3

DI Record Publish Date

June 30, 2018

Package DI Number

30884527004441

Quantity per Package

6

Contains DI Package

10884527004447

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE