Catalog Number

-

Brand Name

Alcon Grieshaber

Version/Model Number

337.84

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"

Yes

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

-

Product Code

HMX

Product Code Name

Cannula, Ophthalmic

Public Device Record Key

9fed3135-fd9e-482e-984f-f194eaba8b23

Public Version Date

July 02, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

17612717071190

Quantity per Package

6

Contains DI Package

07612717071193

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box