Catalog Number

RAR-4057S

Brand Name

Arthrex®

Version/Model Number

RAR-4057S

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

FZW

Product Code Name

EXPANDER, SURGICAL, SKIN GRAFT

Public Device Record Key

def053fa-e322-47f2-b6b7-443b47e1ff51

Public Version Date

July 08, 2021

Public Version Number

3

DI Record Publish Date

June 14, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-