Catalog Number

1-102

Brand Name

OMNI Surgical System (US)

Version/Model Number

FG 05757

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 28, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173332

Product Code

HMZ

Product Code Name

Trabeculotome

Public Device Record Key

f923d797-44c8-45ca-819e-eef6590c675c

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

October 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-