Catalog Number

9004454

Brand Name

Henry Schein

Version/Model Number

9004454

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"

-

For Single-Use

-

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

MVL

Product Code Name

CORD, RETRACTION

Public Device Record Key

5c945367-d6d1-4b78-aa6a-f9f43b597cfe

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 13, 2019

Package DI Number

20304040059443

Quantity per Package

25

Contains DI Package

10304040059446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-