Catalog Number

E10116A0

Brand Name

E10116A0 SMS Gown XL, 2 towels, Sterile

Version/Model Number

E10116A0

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)

Yes

Over the Counter (OTC)

-

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

dbe4f7f4-f6d2-4f58-8e9f-34122cf5451c

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

October 07, 2016

Package DI Number

00816953020190

Quantity per Package

44

Contains DI Package

00816953020183

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case