Catalog Number

-

Brand Name

McKesson

Version/Model Number

183-85-16480-S

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

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

95172e55-e09c-4513-b785-a143bb018b53

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

June 11, 2019

Package DI Number

40612479232165

Quantity per Package

50

Contains DI Package

10612479232157

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case