Catalog Number

-

Brand Name

SURGISTAR

Version/Model Number

188130

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

K961524,K961524

Product Code

HMX

Product Code Name

Cannula, Ophthalmic

Public Device Record Key

0ad45181-2d22-4b60-9808-936cb40d5a0f

Public Version Date

October 07, 2019

Public Version Number

7

DI Record Publish Date

June 06, 2016

Package DI Number

10878799000368

Quantity per Package

5

Contains DI Package

00878799000361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-