Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-OHBFBAAMI3

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FYC

Product Code Name

Gown, Isolation, Surgical

Public Device Record Key

e43d7ee8-f5c5-4973-b5f0-599fc688c246

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 31, 2016

Package DI Number

40612479203240

Quantity per Package

10

Contains DI Package

20612479203239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case