Catalog Number

2143

Brand Name

PremierPro

Version/Model Number

2143

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

FYF

Product Code Name

Cap, Surgical

Public Device Record Key

a5cd59f3-e664-426a-859b-89d33b6b1fd1

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

July 25, 2020

Package DI Number

10818566011869

Quantity per Package

5

Contains DI Package

00818566011862

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case