Catalog Number

10331

Brand Name

C-Core 10331 SurgiSoft Rein XLarge Surgical Gown-

Version/Model Number

10331

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

172fc2e8-142d-45ee-a1cf-d3f88539c48d

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 25, 2016

Package DI Number

00817602020134

Quantity per Package

32

Contains DI Package

00817602020127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case