Catalog Number

68659

Brand Name

ENDODRAPE®

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070406,K070406

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

ec31768d-1883-45ee-ab09-ab6fbe575f48

Public Version Date

October 22, 2019

Public Version Number

1

DI Record Publish Date

October 14, 2019

Package DI Number

B27820689076068659

Quantity per Package

20

Contains DI Package

B27810689076068659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton