Catalog Number

E4302

Brand Name

E4302 Basic Surgical Pack Soft SMS

Version/Model Number

E4302

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

K101598

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

b943005a-cd58-40c0-bf63-33e7acaf5759

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

October 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-