Catalog Number

PT-32245-R-1

Brand Name

MST/Packard A1 .7mm 12˚ Bend Phaco Tip, 45˚

Version/Model Number

PT-32245-R-1

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"

Yes

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

K943672

Product Code

HQC

Product Code Name

Unit, Phacofragmentation

Public Device Record Key

4c4ebdec-8f3b-4787-9782-4a67dae29581

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-