Catalog Number

ATEC NG12-FISCH

Brand Name

ATEC Needle Guide

Version/Model Number

ATEC NG12-FISCH

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K042290,K042290

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

45b4cc07-c808-4dd6-9d2d-b779fec65512

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

September 03, 2015

Package DI Number

15420045503137

Quantity per Package

5

Contains DI Package

05420045503130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX