Catalog Number

-

Brand Name

Leader

Version/Model Number

B FMDLS 0130 R02406 LEA

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

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

FRL

Product Code Name

Fiber, Medical, Absorbent

Public Device Record Key

62270feb-f094-4239-9a92-ba291a6a0774

Public Version Date

March 09, 2020

Public Version Number

1

DI Record Publish Date

February 28, 2020

Package DI Number

10096295134473

Quantity per Package

24

Contains DI Package

00096295134476

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case