Catalog Number

-

Brand Name

N/A

Version/Model Number

TRAY #102A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 19, 2019

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

1736bf50-d8ad-42f4-9559-309f40b0186c

Public Version Date

July 25, 2019

Public Version Number

2

DI Record Publish Date

July 03, 2019

Package DI Number

50884908053925

Quantity per Package

5

Contains DI Package

00884908053920

Package Discontinue Date

July 19, 2019

Package Status

Not in Commercial Distribution

Package Type

BOX