Catalog Number

RUX053501

Brand Name

exGraft

Version/Model Number

RGX053501

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

K183613,K183613

Product Code

DSY

Product Code Name

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Public Device Record Key

2a429922-3b07-47c8-8d6b-d619e6168aa9

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

August 06, 2019

Package DI Number

00818136022786

Quantity per Package

1

Contains DI Package

00818136022380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer/Shipper Box