Catalog Number

-

Brand Name

SURGISTAR

Version/Model Number

885569

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

EMF

Product Code Name

Knife, Surgical

Public Device Record Key

ac2e0cf4-8224-45a6-a8e3-ac66eadd550f

Public Version Date

February 06, 2020

Public Version Number

3

DI Record Publish Date

July 29, 2016

Package DI Number

10878799009286

Quantity per Package

6

Contains DI Package

00878799009289

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-