Catalog Number

PT-30930

Brand Name

MST/Dewey 0.9mm Mini A1 Bent Ph Tip 45deg

Version/Model Number

PT-30930

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

da6dba55-db72-4a65-b760-1cd83815ba99

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

-