Catalog Number

-

Brand Name

Intra-Art Coronary Artery Retraction Clip

Version/Model Number

CRC-3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K882981,K882981

Product Code

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Public Device Record Key

da6cc898-177c-4934-a719-f443e4afe451

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 01, 2017

Package DI Number

B040CRC32

Quantity per Package

1

Contains DI Package

B040CRC31

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-