Catalog Number

PRP2000-1

Brand Name

Eclipse PRP HC

Version/Model Number

PRP2000-1

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

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Public Device Record Key

d799851a-bd5b-4bf1-9871-de13bbb3ad73

Public Version Date

November 06, 2020

Public Version Number

2

DI Record Publish Date

October 04, 2018

Package DI Number

00853602008444

Quantity per Package

12

Contains DI Package

00853602008086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box