Catalog Number

8605U

Brand Name

Kendall

Version/Model Number

8605U

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

MMK

Product Code Name

Container, sharps

Public Device Record Key

2d93fef5-2e28-431a-acbd-9fbb56b1297c

Public Version Date

February 15, 2019

Public Version Number

7

DI Record Publish Date

September 07, 2017

Package DI Number

20884521744643

Quantity per Package

14

Contains DI Package

10884521744646

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE