Catalog Number

E201301

Brand Name

C-Core Drape, Sheet, SMS 40"x63"

Version/Model Number

E201301

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)

-

Over the Counter (OTC)

Yes

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

1c9c3ea2-74d0-44c1-9c2c-642d3a1cd85f

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 15, 2016

Package DI Number

10852205007707

Quantity per Package

60

Contains DI Package

00852205007700

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case