Catalog Number

-

Brand Name

Gonio Left

Version/Model Number

LGP2000-OS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2021

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K875014

Product Code

HQJ

Product Code Name

Implant, Absorbable, (Scleral Buckling Methods)

Public Device Record Key

c8408146-e05a-446a-8373-1232ac00f163

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

October 05, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-