Catalog Number

-

Brand Name

Cardiovascular Procedure Kit

Version/Model Number

76776

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083194,K083194

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

3f2a5dfe-2672-424d-a077-69dc07e37b71

Public Version Date

July 16, 2018

Public Version Number

1

DI Record Publish Date

June 13, 2018

Package DI Number

50699753508205

Quantity per Package

5

Contains DI Package

00699753508200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 Piece Case