Catalog Number

2494

Brand Name

PremierPro

Version/Model Number

2494

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

894acf05-aa02-4cad-8036-e45849c7e464

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

August 02, 2020

Package DI Number

10818566019742

Quantity per Package

100

Contains DI Package

00818566019745

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case