Catalog Number

PRE 2020

Brand Name

PRECISA

Version/Model Number

PRECISA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

-

FDA Premarket Submission

K002944,K002944,K002944

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

6f5027ef-01f2-448c-9ce1-b57653653f3e

Public Version Date

December 27, 2019

Public Version Number

1

DI Record Publish Date

December 19, 2019

Package DI Number

38033003345376

Quantity per Package

10

Contains DI Package

08033003345375

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-