Catalog Number

-

Brand Name

N/A

Version/Model Number

TRAY #4C

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

Yes

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

-

FDA Premarket Submission

-

Product Code

DQX

Product Code Name

Wire, Guide, Catheter

Public Device Record Key

5df9aef1-7600-4b5b-9d0d-bac2c9fa125f

Public Version Date

July 11, 2019

Public Version Number

1

DI Record Publish Date

July 03, 2019

Package DI Number

50884908054403

Quantity per Package

4

Contains DI Package

00884908054408

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX