Catalog Number

762620100

Brand Name

UltraCore™ Biopsy Needle

Version/Model Number

762620100

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

DWO

Product Code Name

Needle, Biopsy, Cardiovascular

Public Device Record Key

b2a54d40-1030-40dd-a33d-74dda095e32a

Public Version Date

July 22, 2022

Public Version Number

1

DI Record Publish Date

July 14, 2022

Package DI Number

20886333006407

Quantity per Package

10

Contains DI Package

00886333006403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box