Catalog Number

-

Brand Name

SURGISTAR, INC.

Version/Model Number

185184

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

b4e98bfc-3b39-4160-8cf7-f3d3d0e53269

Public Version Date

October 07, 2019

Public Version Number

6

DI Record Publish Date

March 21, 2018

Package DI Number

10878799003130

Quantity per Package

5

Contains DI Package

00878799003133

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-