Catalog Number

-

Brand Name

LenSx® SoftFit™

Version/Model Number

8065998275

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

3747c7bb-be35-4e41-b722-01cdd7a3a3f8

Public Version Date

January 24, 2022

Public Version Number

3

DI Record Publish Date

August 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-