Catalog Number

216-2MC

Brand Name

POCKET PAL II

Version/Model Number

216-2MC

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

c63f0ea0-ef3a-4894-96f7-d63de1460b4b

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 13, 2018

Package DI Number

00634782595340

Quantity per Package

18

Contains DI Package

00634782093921

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER