Catalog Number

50321

Brand Name

C-Core 50321 Surgical Gown, Soft SMS, Full Rein Large, Set In-

Version/Model Number

50321

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

2b93604f-688a-4696-b9eb-0d2e9f522af7

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 25, 2016

Package DI Number

00817602021643

Quantity per Package

40

Contains DI Package

00817602021636

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case