Catalog Number

0901005000

Brand Name

PreciseCore

Version/Model Number

0901005000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 05, 2018

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

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

20ca8fa6-bf55-4cc0-8085-fed7abe0d191

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

37613252722275

Quantity per Package

5

Contains DI Package

07613252722274

Package Discontinue Date

January 05, 2018

Package Status

Not in Commercial Distribution

Package Type

pack