Catalog Number

PRP1000

Brand Name

Eclipse PRP

Version/Model Number

PRP1000

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

105dcb56-ad6a-43c3-83b3-9378e699e8ea

Public Version Date

November 06, 2020

Public Version Number

2

DI Record Publish Date

October 04, 2018

Package DI Number

00853602008437

Quantity per Package

12

Contains DI Package

00853602008000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box