Catalog Number

5513205

Brand Name

LEADER

Version/Model Number

5513205

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

IMD

Product Code Name

PACK, HOT OR COLD, DISPOSABLE

Public Device Record Key

f85e0806-b835-4cbd-b273-3a7bf0f41c04

Public Version Date

July 02, 2021

Public Version Number

2

DI Record Publish Date

October 21, 2019

Package DI Number

50096295137342

Quantity per Package

6

Contains DI Package

00096295137347

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE