Catalog Number

DYNJP2378P

Brand Name

Medline

Version/Model Number

DYNJP2378P

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

7ae4679c-e493-495f-b6b9-fc29e7a5cc92

Public Version Date

February 16, 2021

Public Version Number

1

DI Record Publish Date

February 08, 2021

Package DI Number

20888277725659

Quantity per Package

22

Contains DI Package

10888277725652

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE