Catalog Number

5702652

Brand Name

Henry Schein

Version/Model Number

5702652

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EFN

Product Code Name

COTTON, ROLL

Public Device Record Key

098581ec-f696-44b1-8f1b-7fd24b4f329b

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

May 10, 2021

Package DI Number

20304040153714

Quantity per Package

25

Contains DI Package

10304040153717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case