Catalog Number

26123

Brand Name

PremierPro

Version/Model Number

26123

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)

-

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

11887001-3d1c-4716-89b8-5170fdcf57da

Public Version Date

August 07, 2020

Public Version Number

1

DI Record Publish Date

July 30, 2020

Package DI Number

10818566011531

Quantity per Package

3

Contains DI Package

00818566011534

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case