Catalog Number

NAC-1820 ULTRA

Brand Name

Automatic Cutting Needle

Version/Model Number

NAC-1820 ULTRA

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

K982401,K982401,K982401

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

8d38df43-962d-47e2-9e38-833ddcbdf27a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20813079020978

Quantity per Package

10

Contains DI Package

10813079020971

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Carton