Catalog Number

11348CS

Brand Name

Medline Industries, Inc.

Version/Model Number

11348CS

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

K801550,K801550

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

04d020ca-9df8-4d7c-9ca4-f15e96fa516f

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

November 07, 2016

Package DI Number

40884389218816

Quantity per Package

100

Contains DI Package

10884389218815

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE