Catalog Number

-

Brand Name

Arthrex BioExpress

Version/Model Number

ABS-10053-15-4

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

K151543,K151543,K151543

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

8da072ab-1016-43df-9276-f2837db05f36

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 25, 2021

Package DI Number

10815634020709

Quantity per Package

5

Contains DI Package

00815634020702

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack