Catalog Number

570057

Brand Name

KENTEX

Version/Model Number

570057

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

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

IME

Product Code Name

Pack, Hot Or Cold, Reuseable

Public Device Record Key

f4bd291b-b536-4235-9ef6-ce6fa4bfd736

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 27, 2016

Package DI Number

10852244007560

Quantity per Package

24

Contains DI Package

00852244007563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-