Catalog Number

DYNJ0561216F

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJ0561216F

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

K140539

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

98c91f7c-3458-40d2-b6a0-3c26ed348a75

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

September 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-