Catalog Number

3005.F106

Brand Name

Phaco fragmentation needles, 23G / 0.6 mm, incl. needle wrench.

Version/Model Number

3005.F106

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

-

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

K081877,K081877

Product Code

HQC

Product Code Name

Unit, Phacofragmentation

Public Device Record Key

e0ddead7-f3ab-4dc8-a709-4475901bdbe8

Public Version Date

May 08, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-