Catalog Number

SM-PRP-15

Brand Name

Amplifine

Version/Model Number

15ml

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)

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

2aaf3851-f4c6-40ed-b98a-acd645668c78

Public Version Date

February 11, 2022

Public Version Number

2

DI Record Publish Date

December 31, 2020

Package DI Number

10350224000100

Quantity per Package

3

Contains DI Package

00350224000103

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton