Catalog Number

-

Brand Name

Surgimedics®

Version/Model Number

9S-5501

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

b4132a71-5a88-408e-be4d-b244ff804025

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10814716020415

Quantity per Package

5

Contains DI Package

00814716020418

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-