Catalog Number

E233106N.

Brand Name

E233106N. Femoral Radial Angio Drape 372x290cm (SMALL BOX)

Version/Model Number

E233106N.

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)

-

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

eabdd081-80f1-4bf0-a837-7d1063ac3071

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

October 10, 2016

Package DI Number

00816953020619

Quantity per Package

12

Contains DI Package

00816953020602

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case