Catalog Number

-

Brand Name

Gaasterland 1x Four Mirror Gonio Lens w/Small Ring 15mm O.D.

Version/Model Number

OG4MG-1X-15

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

-

Product Code

HKS

Product Code Name

Prism, Gonioscopic

Public Device Record Key

02d1fc1d-648b-4869-94fa-f8fc4efe9a28

Public Version Date

June 18, 2019

Public Version Number

1

DI Record Publish Date

June 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-