Catalog Number

DYNJP1060A

Brand Name

Medline

Version/Model Number

DYNJP1060A

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

32feec4b-2125-4cfe-a75d-cbd9f5ae875d

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

October 14, 2016

Package DI Number

40080196915034

Quantity per Package

4

Contains DI Package

10080196915033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-