Catalog Number

-

Brand Name

McKesson

Version/Model Number

1800P

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

KGN

Product Code Name

Dressing, Wound, Collagen

Public Device Record Key

c285fd7c-cb1c-44b6-9f83-4651f8e4bcfb

Public Version Date

July 17, 2020

Public Version Number

2

DI Record Publish Date

May 27, 2020

Package DI Number

00612479256712

Quantity per Package

10

Contains DI Package

00612479256705

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box