Catalog Number

-

Brand Name

Accu-Beam

Version/Model Number

9501-34/70

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K952006

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

af1b113d-6a8a-47dc-b206-d7b000d47f14

Public Version Date

March 03, 2022

Public Version Number

1

DI Record Publish Date

February 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-