Catalog Number

7430001

Brand Name

Diode Laser Tips

Version/Model Number

PI Pro Tips, Surgical, 3-4

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

Yes

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

K163128,K163128

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

3bb431a1-6d5c-4928-8e33-0d3a2f9f783a

Public Version Date

July 29, 2020

Public Version Number

5

DI Record Publish Date

January 13, 2017

Package DI Number

00647529003206

Quantity per Package

20

Contains DI Package

00647529003176

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box