Catalog Number

-

Brand Name

Disposable Vitrectomy Lens 30°, 10 PK

Version/Model Number

ODV3P

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

K012096

Product Code

HJK

Product Code Name

Lens, Contact, Polymethylmethacrylate, Diagnostic

Public Device Record Key

782e8d40-c226-4fe3-8b4f-ee224fe2fc38

Public Version Date

June 19, 2019

Public Version Number

1

DI Record Publish Date

June 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-