Catalog Number

-

Brand Name

JosNoe Medical Inc

Version/Model Number

PS-500

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

NWV

Product Code Name

Laparoscopic Accessories, Gynecologic

Public Device Record Key

699a5ce9-3a79-41a2-92fb-6842f47f469a

Public Version Date

September 05, 2019

Public Version Number

2

DI Record Publish Date

July 16, 2019

Package DI Number

00850003294117

Quantity per Package

30

Contains DI Package

00850003294001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case