Catalog Number

CDS985466C

Brand Name

Medline Industries, Inc.

Version/Model Number

CDS985466C

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)

Yes

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

-

Product Code

FDE

Product Code Name

laparoscopy kit

Public Device Record Key

3e2a903c-7c70-4632-ac2c-4dd00130e9ad

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

August 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-