Catalog Number

SA-DRPSPLTSHT

Brand Name

Medline Industries, Inc.

Version/Model Number

SA-DRPSPLTSHT

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

-

Product Code

FDE

Product Code Name

laparoscopy kit

Public Device Record Key

cc5794ff-9ef2-4542-ada9-4f922628b69d

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

November 07, 2016

Package DI Number

40080196810032

Quantity per Package

24

Contains DI Package

10080196810031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-