Catalog Number

QIG1000-1

Brand Name

Qigenix PRP

Version/Model Number

QIG1000-1

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

aaf00160-f07a-4ce5-aa8a-a958ecf4b655

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-