Catalog Number

CD1115/B

Brand Name

Preston™

Version/Model Number

00884450411803

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DWO

Product Code Name

NEEDLE, BIOPSY, CARDIOVASCULAR

Public Device Record Key

b40bb558-7a37-4b99-8b29-d4d3795a522b

Public Version Date

November 20, 2019

Public Version Number

1

DI Record Publish Date

November 12, 2019

Package DI Number

10884450411800

Quantity per Package

14

Contains DI Package

00884450411803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-