Catalog Number

SLC51LCHEW

Brand Name

CARDINAL HEALTH

Version/Model Number

SLC51LCHEW

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"

Yes

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

-

Product Code

FDE

Product Code Name

laparoscopy kit

Public Device Record Key

0d7b298a-3449-4380-9d25-a7b6163066f0

Public Version Date

July 23, 2018

Public Version Number

3

DI Record Publish Date

August 19, 2015

Package DI Number

50887488019084

Quantity per Package

2

Contains DI Package

00887488019089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE