Catalog Number

-

Brand Name

Ion

Version/Model Number

490127

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"

-

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

-

Product Code

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

1575231b-193a-4d95-b5f5-5bc5840d1381

Public Version Date

September 11, 2020

Public Version Number

1

DI Record Publish Date

September 03, 2020

Package DI Number

10886874119591

Quantity per Package

10

Contains DI Package

00886874119594

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX