Catalog Number

-

Brand Name

SURGISTAR

Version/Model Number

880350

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

6fd1411b-0707-4e14-a6bc-9f5d760002fa

Public Version Date

February 06, 2020

Public Version Number

3

DI Record Publish Date

July 28, 2016

Package DI Number

10878799008357

Quantity per Package

6

Contains DI Package

00878799008350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-