Catalog Number

-

Brand Name

Oertli®

Version/Model Number

VV104010

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

6becd738-2fec-4164-bc97-1a54e55a31c5

Public Version Date

December 13, 2021

Public Version Number

5

DI Record Publish Date

September 19, 2016

Package DI Number

07630003913521

Quantity per Package

10

Contains DI Package

07630003903829

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-