Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-63215

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

GDX

Product Code Name

Scalpel, One-Piece

Public Device Record Key

1ded9f3f-0d7a-40ac-9aaf-6e4acd37570d

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

July 20, 2020

Package DI Number

20612479163557

Quantity per Package

10

Contains DI Package

10612479163543

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box