Catalog Number

-

Brand Name

DirectVision

Version/Model Number

MA100282

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110214,K110214

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

d13bd72d-6e57-490e-a09c-529c953821bb

Public Version Date

December 04, 2020

Public Version Number

9

DI Record Publish Date

September 23, 2016

Package DI Number

10855308006004

Quantity per Package

10

Contains DI Package

00855308006007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton