Catalog Number

58813

Brand Name

Medline Industries, Inc.

Version/Model Number

58813

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

MCY

Product Code Name

Wound dressing kit

Public Device Record Key

55a20bcf-29c1-4cbd-bcde-3e485076554d

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

January 27, 2019

Package DI Number

40888277928405

Quantity per Package

30

Contains DI Package

10888277928404

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE