Catalog Number

0644-016-01

Brand Name

Slimline™ EZ SIS 200

Version/Model Number

Slimline™ EZ SIS 200

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

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

6846518c-3675-4978-a649-19a31de0c06b

Public Version Date

October 13, 2022

Public Version Number

2

DI Record Publish Date

September 04, 2022

Package DI Number

17290109147045

Quantity per Package

3

Contains DI Package

07290109147048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-