Catalog Number

-

Brand Name

SURGISTAR

Version/Model Number

585010

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

OKS

Product Code Name

Lacrimal Stents And Intubation Sets

Public Device Record Key

cfb05060-ab0c-4a81-9d9d-e8bac2d95329

Public Version Date

December 11, 2019

Public Version Number

3

DI Record Publish Date

August 02, 2016

Package DI Number

10878799008173

Quantity per Package

3

Contains DI Package

00878799008176

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-