Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-3M-1248

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K893814,K893814

Product Code

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

55443e97-7a35-4e92-bbdd-001d1b98925c

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 12, 2018

Package DI Number

40612479123937

Quantity per Package

10

Contains DI Package

20612479123667

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case