Catalog Number

195326

Brand Name

Percutaneous Entry Needle

Version/Model Number

195326

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

K772369,K772369,K772369

Product Code

DRC

Product Code Name

Trocar

Public Device Record Key

915d5b21-94b7-4a23-b99c-3cd9cf26b060

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 10, 2016

Package DI Number

10886333208460

Quantity per Package

10

Contains DI Package

00886333208463

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box