Catalog Number

PRP2000

Brand Name

Eclipse PRP HC

Version/Model Number

PRP2000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

-

Product Code Name

-

Public Device Record Key

f9e048dd-957a-4ac2-9607-49dc649a5a59

Public Version Date

July 30, 2021

Public Version Number

4

DI Record Publish Date

October 04, 2018

Package DI Number

10853602008076

Quantity per Package

12

Contains DI Package

00853602008079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box