Catalog Number

-

Brand Name

Surgistar

Version/Model Number

101011

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

e33af4ac-dc98-45a6-acc7-00edb56cf834

Public Version Date

March 04, 2021

Public Version Number

1

DI Record Publish Date

February 24, 2021

Package DI Number

10878799004960

Quantity per Package

10

Contains DI Package

00878799004963

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-