Catalog Number

DYNJP2907T

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

DYNJP2907T

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

1e4a281e-4adf-4b70-bf8c-2911360cd65f

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

March 16, 2021

Package DI Number

20888277629322

Quantity per Package

24

Contains DI Package

10888277629325

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE