Catalog Number

-

Brand Name

exGraft

Version/Model Number

RGX222501

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K202471,K202471

Product Code

DSY

Product Code Name

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Public Device Record Key

226f580c-75d1-42c2-b196-deb837ffd2f2

Public Version Date

February 09, 2021

Public Version Number

1

DI Record Publish Date

February 01, 2021

Package DI Number

00818136020850

Quantity per Package

1

Contains DI Package

00818136020331

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer/Shipper Box