Catalog Number

-

Brand Name

Planatome®

Version/Model Number

PL-11

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GES

Product Code Name

Blade, Scalpel

Public Device Record Key

570c940c-8108-448e-8a1e-b9a1048be1dd

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

October 01, 2020

Package DI Number

00860003534663

Quantity per Package

10

Contains DI Package

00860003534618

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box