Catalog Number

ND-FS

Brand Name

Fenestrated NeoDrape

Version/Model Number

ND-FS

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

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

-

Product Code

FME

Product Code Name

Gown, Examination

Public Device Record Key

2c86a165-b5c1-4e98-8f0d-ca856e2e418a

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

May 19, 2020

Package DI Number

20817584013371

Quantity per Package

40

Contains DI Package

10817584013374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case