Catalog Number

19318

Brand Name

ccore

Version/Model Number

19318

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

c85c100b-399c-4cc0-884a-bcbc6077957d

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 26, 2020

Package DI Number

00817602022893

Quantity per Package

17

Contains DI Package

00817602022886

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case