Catalog Number

-

Brand Name

DIGITAL IVUS STERILE EQUIPEMENT COVER

Version/Model Number

5902VC

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

K052395,K052395,K052395

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

b779c925-bdf9-4153-880d-885a10e9cdaa

Public Version Date

February 28, 2022

Public Version Number

6

DI Record Publish Date

March 02, 2017

Package DI Number

20845225012698

Quantity per Package

10

Contains DI Package

10845225012691

Package Discontinue Date

-

Package Status

-

Package Type

Box