Eclipse PRP - Eclipse PRP Patient Kit - 11ml PRP Tube Only - ECLIPSE

Duns Number:969752364

Device Description: Eclipse PRP Patient Kit - 11ml PRP Tube Only

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More Product Details

Catalog Number

PRP1000-1

Brand Name

Eclipse PRP

Version/Model Number

PRP1000-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Device Record Status

Public Device Record Key

f1045bb8-5e62-4815-b5a8-a0d6c4793bbf

Public Version Date

November 06, 2020

Public Version Number

2

DI Record Publish Date

October 04, 2018

Additional Identifiers

Package DI Number

00853602008420

Quantity per Package

12

Contains DI Package

00853602008017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ECLIPSE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14