Catalog Number

SABD-2020-15-T

Brand Name

Single Action Biopsy Device

Version/Model Number

SABD-2020-15-T

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

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

9455b4bd-ad8b-4bca-8169-7b317d554c72

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

20886333219418

Quantity per Package

10

Contains DI Package

00886333219414

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box