Catalog Number

-

Brand Name

Oertli®

Version/Model Number

VV105110

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

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

HQC

Product Code Name

Unit, Phacofragmentation

Public Device Record Key

c2618248-e890-42a9-9378-b2a0881305e1

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

June 24, 2020

Package DI Number

07630003913798

Quantity per Package

10

Contains DI Package

07630003912340

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-