Catalog Number

10221

Brand Name

C-Core 10221 SurgiSoft Fabric Rein Large Surgical Gown-

Version/Model Number

10221

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)

-

Over the Counter (OTC)

Yes

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

f05b8dce-c6ca-447d-a9a7-9381e898ed0b

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 25, 2016

Package DI Number

00817602020226

Quantity per Package

36

Contains DI Package

00817602020042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case