Catalog Number

30331

Brand Name

C-Core 30331 SMS Surgical Gown Rein XLarge-

Version/Model Number

30331

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

K101598,K101598

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

4f3adc59-e96c-41c9-9693-cd7d6bbfde40

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 26, 2016

Package DI Number

00817602021520

Quantity per Package

32

Contains DI Package

00817602021513

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case