Catalog Number

-

Brand Name

SURGISTAR, INC.

Version/Model Number

131618BNS

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

-

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

86ab7c17-ae03-4f34-8442-a30d60f5b913

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

December 27, 2018

Package DI Number

10878799003253

Quantity per Package

100

Contains DI Package

00878799003256

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-