Catalog Number

116W

Brand Name

Pocket Pal II™

Version/Model Number

116W

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRW

Product Code Name

Scissors, General, Surgical

Public Device Record Key

516d5612-7fd4-4504-acf7-dd607d321fe5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 30, 2016

Package DI Number

00634782585129

Quantity per Package

24

Contains DI Package

00634782083724

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case