Catalog Number

40131

Brand Name

C-Core 40131 Surgical Gown, STD, AAMI IV, X-Lge, Set in-

Version/Model Number

40131

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

K120045,K120045

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

25ed22d7-6c31-4cad-af90-469cb7e1a449

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 27, 2016

Package DI Number

00817602021582

Quantity per Package

36

Contains DI Package

00817602021575

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case