Catalog Number

7123-CE-0650

Brand Name

GMPP DCD Small Spot Option Kit, w/Fiber Assembly

Version/Model Number

7123-CE-0650

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K201111

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

b69a4bfb-3ef7-426b-bc0d-b0909e20eb3b

Public Version Date

October 12, 2022

Public Version Number

3

DI Record Publish Date

January 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-