Catalog Number

-

Brand Name

E104162N Gown,XL-XL,Std,Set in, with Velcro(AAMI IV Breathable mtl.)

Version/Model Number

E104162N

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

bc3ef6f4-ffac-4c7f-99a9-6f8c5d612e86

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 28, 2016

Package DI Number

00816953020336

Quantity per Package

360

Contains DI Package

00816953020329

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case