Catalog Number

4100M34

Brand Name

CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING WITH HOLDER

Version/Model Number

4100

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"

-

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

K083623

Product Code

KRH

Product Code Name

RING, ANNULOPLASTY

Public Device Record Key

bb25142c-6215-4320-a169-80491d53e606

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-