Catalog Number

PT-32430-B

Brand Name

MST/Packard .7mm strt p tp Dwy 30º

Version/Model Number

PT-32430-B

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

6100a9ed-fe82-48c3-9375-2e1692ed3832

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-