Catalog Number

DYNDH1594

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNDH1594

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"

Yes

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

a00d7bc0-bdd7-486a-bc4a-95b8b20d03d9

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

August 30, 2021

Package DI Number

40193489849227

Quantity per Package

20

Contains DI Package

10193489849226

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE