Catalog Number

66021980

Brand Name

RENASYS AB DRSG KIT W/SOFTPORT

Version/Model Number

66021980

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K143133,K143133

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

234658cd-eb77-4c28-ab39-341b124bf45b

Public Version Date

January 25, 2021

Public Version Number

2

DI Record Publish Date

April 24, 2020

Package DI Number

30040565127256

Quantity per Package

5

Contains DI Package

00040565127255

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case