Catalog Number

-

Brand Name

SUPERBIUM

Version/Model Number

APMD116

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153229

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

082f24c3-db86-44a8-a83f-0797df0ac976

Public Version Date

August 24, 2021

Public Version Number

4

DI Record Publish Date

November 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-