Catalog Number

-

Brand Name

CLS

Version/Model Number

CT1001

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

-

Product Code

NKC

Product Code Name

Tubing/Tubing With Filter, Insufflation, Laparoscopic

Public Device Record Key

25162b89-3f38-4d88-ac48-412f2dcc5fd1

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

December 05, 2017

Package DI Number

20864039000400

Quantity per Package

6

Contains DI Package

10864039000403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-