Catalog Number

SOFTEC I

Brand Name

SOFTEC I

Version/Model Number

SOFTECI+24.0

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

P090022

Product Code

HQL

Product Code Name

Intraocular Lens

Public Device Record Key

d2886e75-6ac5-402b-807a-a2746973e306

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

August 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-