Catalog Number

E103160

Brand Name

C-Core Surgical Soft SMS Gown w/ Standard SMS Rein. X-Large

Version/Model Number

E103160

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)

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

d71ecac4-229b-4f20-9b77-d7ad57a6476f

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

10852205007684

Quantity per Package

32

Contains DI Package

00852205007687

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case