Catalog Number

SF-3XXL

Brand Name

SF-3XXL Solofit AAMI III SMS Gown XX-Large

Version/Model Number

SF-3XXL

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)

-

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

40969518-44a1-4afe-9cf5-5b454b4b0c91

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

March 02, 2017

Package DI Number

00854150007088

Quantity per Package

28

Contains DI Package

00854150007071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case