Catalog Number

PRE 1610

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

e4f4f14c-cd61-4f92-9d72-920d19a302ad

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

28033003345232

Quantity per Package

5

Contains DI Package

08033003345238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-