Catalog Number

PT-32430-1

Brand Name

MST/Packard .7mm straight PT Dwy 30°

Version/Model Number

PT-32430-1

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

Yes

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

7d36ecab-ce01-4b10-bc52-890e174a2377

Public Version Date

January 17, 2020

Public Version Number

3

DI Record Publish Date

February 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-