Catalog Number

-

Brand Name

New Balance

Version/Model Number

N915 Black X-Large

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"

-

For Single-Use

-

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

K123398,K123398

Product Code

DWL

Product Code Name

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Public Device Record Key

45b3ac3d-0c8f-41c2-bcc9-cefd774223c2

Public Version Date

July 07, 2020

Public Version Number

5

DI Record Publish Date

September 30, 2016

Package DI Number

20888625011397

Quantity per Package

6

Contains DI Package

00888625011393

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Baler Bag