Catalog Number

-

Brand Name

SURGISTAR, INC.

Version/Model Number

131617

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

42b744a7-44c3-41b6-90df-98b3a39d8003

Public Version Date

October 07, 2019

Public Version Number

9

DI Record Publish Date

June 29, 2017

Package DI Number

10878799002553

Quantity per Package

10

Contains DI Package

00878799002556

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-