Catalog Number

7123-CE-0629

Brand Name

ACC HAND PIECE, MEDIUM SPOT, GMPP

Version/Model Number

7123-CE-0629

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

6462074c-9aa7-42dd-a888-53ec97cd580d

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

-