Catalog Number

ABS-10060R

Brand Name

Arthrex®

Version/Model Number

ABS-10060R

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

-

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

ee98405d-8cac-467f-a0ea-5c108b22e533

Public Version Date

February 22, 2022

Public Version Number

4

DI Record Publish Date

August 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-