Catalog Number

PIN-15

Brand Name

PERCUTANEOUS INTRO NEEDLE F/G

Version/Model Number

PIN-15

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"

Yes

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

03f580ca-75fc-416d-9578-408201e6aa34

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 02, 2017

Package DI Number

20858690006437

Quantity per Package

16

Contains DI Package

10858690006430

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case