Catalog Number

5001-90015

Brand Name

K2M Fenestrated Tap System

Version/Model Number

5001-90015

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

K152872

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

22cfc4bb-e377-4541-8476-43bf68abf3da

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

October 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-