Catalog Number

19317

Brand Name

ccore

Version/Model Number

19317

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

K101689,K101689

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

b3d27142-bed7-402e-90f2-cbc53ed6cb86

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 26, 2020

Package DI Number

00817602022879

Quantity per Package

80

Contains DI Package

00817602022862

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case