Catalog Number

-

Brand Name

McKesson

Version/Model Number

81-31

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

MCZ

Product Code Name

Suture Removal Kit

Public Device Record Key

92b279d4-a89d-4cf5-b697-19140ae32bce

Public Version Date

June 19, 2020

Public Version Number

1

DI Record Publish Date

June 11, 2020

Package DI Number

00815555023349

Quantity per Package

20

Contains DI Package

00815555023332

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case