Catalog Number

460034MM

Brand Name

COSGROVE-EDWARDS ANNULOPLASTY BAND WITH TEMPLATE/LANYARD

Version/Model Number

4600

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

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

K923367

Product Code

KRH

Product Code Name

RING, ANNULOPLASTY

Public Device Record Key

3b47c62e-200a-4a9b-a1e3-327049e505ba

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

-