Catalog Number

-

Brand Name

Dermastat

Version/Model Number

Dermastat 2mm

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

K132185

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

ac5d3647-63cb-4e02-b23e-92d94a0a6385

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

July 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-