Catalog Number

E632203NEO-01N

Brand Name

Hays Innovations

Version/Model Number

E632203NEO-01N

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

a09fd543-b2e1-42b4-a2e9-dd4ab9629a17

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Package DI Number

00869566000219

Quantity per Package

10

Contains DI Package

00869566000202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box