Catalog Number

10231

Brand Name

C-Core 10231 SurgiSoft Fabric Rein XL Surgical Gown-

Version/Model Number

10231

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

958a9f94-5ba6-40e1-b32a-1b42b62b231f

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 25, 2016

Package DI Number

00817602020073

Quantity per Package

32

Contains DI Package

00817602020066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case